U.S.

Department of Health and Human Services Mfr Report #: 2080953-2020-44600

Food and Drug Administration
For use by user-facilities, UF/Importer Report #:
MEDWATCH importers, distributors and manufacturers
FDA eSubmitter Generated Form 3500A Form Code: 564564
for MANDATORY reporting
Exemption Number: 5645646
A. PATIENT INFORMATION
1. Patient Identifier (In confidence) 2. Age at Time of Event, Date of Birth 3. Sex 4. Weight
A564446 33 Year(s), 19-Jun-1987 Intersex 120 Kilogram(s)
5. Ethnicity
( ) Hispanic/Latino (•) Not Hispanic/Latino
6. Race
[ ] Asian [ ] White
[ ] American Indian or Alaskan Native [ ] Native Hawaiian or Other Pacific Islander
[X] Black or African American
B. ADVERSE EVENT OR PRODUCT PROBLEM
1. [X] Adverse Event and/or [X] Product Problem (e.g., defects/malfunctions)

2. Outcomes Attributed to Adverse Event (Checked all that apply)

[X] Death: 10-May-2020 (dd-mmm-yyyy) [X] Disability or Permanent Damage
[ ] Life-threatening [ ] Congenital Anomaly/Birth Defect
[X] Hospitalization (initial or prolonged) [ ] Other Serious or Important Medical Events
[ ] Required Intervention to Prevent Permanent Impairment/Damage
3. Date of Event (dd-mmm-yyyy) 4. Date of this Report (dd-mmm-yyyy)
10-May-2020 10-May-2020
5. Describe Event or Problem
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6. Relevant Tests/Laboratory Data, Including Dates
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7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)
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C. SUSPECT PRODUCT(S)
Drug Product #
1
Drug Type: Approval #: If IND/Pre-ANDA, Give Protocol #:
NDA NDA56465 IND54564564
1a. Name and Strength: 1c. NDC # or Unique ID:
445 45
1b. Manufacturer/Compounder: 1d. Lot #:
45 654
2a. List Medical Product and Treatment Given at the Same Time Of the Event and Date
See Section D10 for all Concomitant Medical Product and Therapy Date information
3a. Dose: 3b. Dose Unit: 3c. Number of separate dosages: 3d. Frequency: 3e. Frequency Unit:
45 005 654 545 802
3f. Route Used: 4. Treatment Dates/Therapy Dates:
006 10-May-2020 to 20-May-2020
5. Diagnosis for Use (Indication): 6. Product Type:
U.S. Department of Health and Human Services Mfr Report #: 2080953-2020-44600
Food and Drug Administration
For use by user-facilities, UF/Importer Report #:
MEDWATCH importers, distributors and manufacturers
FDA eSubmitter Generated Form 3500A Form Code: 564564
for MANDATORY reporting
Exemption Number: 5645646

Test C5 [X] OTC [X] Generic

[X] Compounded [X] Biosimiar
[X] Pre-ANDA [X] Pre-1938
7. Expiration Date
22-May-2080
8. Event Abated After Use Stopped or Dose
Reduced?
( ) Yes ( ) No (•) Doesn't Apply
9. Event Reappeared After Reintroduction?
( ) Yes (•) No ( ) Doesn't Apply
Drug Product #
2
Drug Type: Approval #: If IND/Pre-ANDA, Give Protocol #:
ANDA ANDA9798797 PRE969696
1a. Name and Strength: 1c. NDC # or Unique ID:
8491861 7928578
1b. Manufacturer/Compounder: 1d. Lot #:
3759837 5732837
2a. List Medical Product and Treatment Given at the Same Time Of the Event and Date
See Section D10 for all Concomitant Medical Product and Therapy Date information
3a. Dose: 3b. Dose Unit: 3c. Number of separate dosages: 3d. Frequency: 3e. Frequency Unit:
54 028 159 532 802
3f. Route Used: 4. Treatment Dates/Therapy Dates:
004 01-May-2020 to 20-May-2020
5. Diagnosis for Use (Indication): 6. Product Type:
Test 2 C5 [ ] OTC [ ] Generic
[X] Compounded [ ] Biosimiar
[X] Pre-ANDA [X] Pre-1938
7. Expiration Date
22-May-2081
8. Event Abated After Use Stopped or Dose
Reduced?
( ) Yes (•) No ( ) Doesn't Apply
9. Event Reappeared After Reintroduction?
(•) Yes ( ) No ( ) Doesn't Apply
D. SUSPECT MEDICAL DEVICE
1. Brand Name 2. Common Device Name
Brand ABC Device Name 123, Product Code: MQP
3. Manufacturer Name, City and State 4. Model # Catalog #
Company D3 Model223 786876
Test D3 Address 1
Serial # Lot #
Test D3 Address 2
City D3, State D3 4546546546, XQZ 87687 78897
Fax:122-578-97875454 Expiration Date (dd-mmm-yyyy)
Email:dhivya.swaminathan@fda.hhs.gov 12-May-2048
Unique Identifier (UDI) #
91465465465462
5. Operator of Device 6a. If Implanted, Give Date (dd-mmm- 6b. If Explanted, Give Date (dd-mmm-
yyyy) yyyy)
Patient/Consumer
14-May-2020 14-May-2020
7a. Is this a Single-Use Device that was reprocessed and Reused on a Patient? 7b. If yes, Enter Name and Address of Reprocessor
U.S. Department of Health and Human Services Mfr Report #: 2080953-2020-44600
Food and Drug Administration
For use by user-facilities, UF/Importer Report #:
MEDWATCH importers, distributors and manufacturers
FDA eSubmitter Generated Form 3500A Form Code: 564564
for MANDATORY reporting
Exemption Number: 5645646

(•) Yes ( ) No Company D7b

Address D7B 1
Address D7B 2
City D7B, State D7B 1239798765, CUW
Telephone:231-479-8798798746
Fax:321-089-7987072116
Email:dhivya.swaminathan@fda.gov
8. Was this device serviced by a third party? 9. Device Available for Evaluation? (Do not send to FDA)
( ) Yes (•) No ( ) Unknown (•) Yes
( ) No
[X] Returned to Manufacturer: 13-May-2020 (dd-mmm-yyyy)
10. ConComitant Medical Products and Therapy Dates (Excludes treatment of event)
D10 Test 10-May-2020 (dd-mmm-yyyy)
E. INITIAL REPORTER
1. Name and Address 2. Health Professional?
Ms. Dhivya Swaminathan ( ) Yes (•) No
Company E1
3. Occupation
Address 1 E1
Address 1 E1 Third Party Servicer
City E1, MD 20871-3221, USA 4. Initial Reporter Also Sent Report to FDA?
Telephone:(321) 346-5465 ( ) Yes (•) No ( ) Unk
Fax:(123) 987-9878
Email:dhivya.swaminathan@hotmail.com
F. FOR USE BY USER FACILITY/IMPORTER (Devices Only)
1. User Facility or Importer 2. User Facility/Importer Report Number
( ) User Facility ( ) Importer
3, 4, and 5. User Facility or Importer Name/Address, Contact Person, and 6. Date UF/Importer Became Aware of Event (dd-mmm-yyyy)
Phone Number
22-Dec-2019
Ms. Dhivya Swaminathan
Address 1 F35 7. Type of Report
Address 2 F35 ( ) Initial (•) Follow-up #: 1
City F35, State F35 0466876545, DJI
8. Date of This Report (dd-mmm-yyyy) 9. Approximate Age of Device
Telephone:213-987-9876546546 Ext: 2131
Fax:322-123-2398789799 10-May-2020 54 Months(s)
Email:dhivya.swaminathan@gmail.com
10. Adverse Event Problem (Refer to coding manual) 14. Manufacturer Name/Address
Health Effect - Clinical Code: Company F14
Health Effect - Impact Code: Address1 F14
Address 2 F14
Medical Device Problem Code:
Button, KY 56464-6545, USA
Component Code: Fax:(345) 646-7879
11. Report Sent to FDA? Email:dhivya.swaminathan@instagram.com
(•) Yes: 10-May-2020 (dd-mmm-yyyy) ( ) No
12. Location Where Event Occurred
Outpatient Treatment Facility
13. Report Sent to Manufacturer?
(•) Yes: 05/11/2020 (dd-mmm-yyyy) ( ) No
G. ALL MANUFACTURERS
1. Contact Office (and Manufacturing Site for Devices) or Compounding 1. Contact Office - Manufacturing Site
Outsourcing Facility Company ContG1
Ms. Dhivya Swaminathan Address 1 Cont G1
LALA Address 2 Cont G1
4747 Lala Avenue G1 City 1, NV 21324-5564, USA
Lala, AR 20849-2121, USA Telephone:(123) 132-1321 Ext: 2131
Telephone:(159) 753-8624 Ext: 5546 Fax:(231) 296-8779
Fax:(545) 456-4646 Email:dhivya@fda.gov
Email:dhivya.swaminathan@lala.com
U.S. Department of Health and Human Services Mfr Report #: 2080953-2020-44600
Food and Drug Administration
For use by user-facilities, UF/Importer Report #:
MEDWATCH importers, distributors and manufacturers
FDA eSubmitter Generated Form 3500A Form Code: 564564
for MANDATORY reporting
Exemption Number: 5645646
2. Report Source (Check all that apply) 3. Date Received by Manufacturer (dd-mmm-yyyy)
[ ] Foreign [ ] Health Professional 10-May-2020
[ ] Study [ ] User Facility
4. Premarket Identification PMA/510(k):
[X] Literature [ ] Company Representative
[ ] Consumer [X] Distributor/Importer [X] Combination Product Device BLA: BL465464
[ ] Other 5. If IND/PreANDA, Give Protocol #

6. Type of Report 7. Adverse Event Term(s) 8. Manufacturer Report Number

[ ] 5-day [ ] Periodic Test G7 Test G7 Test G7 Test 2080953-2020-44600
[ ] 7-day [ ] Initial G7 Test G7 Test G7 Test G7
Test G7 Test G7 Test G7 Test
[ ] 15-day [X] Follow-up #: 1 G7 Test G7 Test G7 Test G7
[X] 30-day
H. DEVICE MANUFACTURERS ONLY
1. Type of Reportable Event 2. If Follow-up, What Type? 3. Device Evaluated by Manufacturer?
( ) Death [ ] Correction ( ) Yes (•) No
(•) Serious Injury [ ] Additional Information Device evaluation anticipated, but not yet begun
( ) Malfunction [X] Response to FDA Request [X] Not Returned to Manufacturer
[X] Summary Report [X] Device Evaluation
[X] Evaluation Summary Attached
No. of Events Summarized: 123
4. Device Manufacture Date (dd-mmm-yyyy) 6. Adverse Event Problem (Refer to coding manual)
01-Apr-2010 Health Effect - Clinical Code: 2688 - 1926 - 2111 - 2112 - 2113 - 2114 -
2115
5. Labeled for Single Use?
Health Effect - Impact Code: 403 - 404 - 4221 - 405 - 552 - 407
( ) Yes (•) No
Medical Device Problem Code: 4010 - 4009 - 1384 - 4001 - 1112 -
3022 - 4030
Component Code: 3049 - 419
Type of Investigation: 3331 - 4112 - 4113 - 4114 - 4117 - 4109 - 4116
Investigation Findings: 401 - 548 - 402 - 431 - 3028
Investigation Conclusions: 50 - 4316 - 12 - 19 - 4311 - 4312 - 25 - 24
7. If Remedial Action initiated, Check Type 8. Usage of Device 9. If action reported to FDA under 21
USC 360i(f), list correction/removal
[ ] Recall [ ] Notification (•) Initial Use of Device reporting number
[ ] Repair [ ] Inspection ( ) Reuse 13232121
[X] Replace [X] Patient Monitoring ( ) Unknown
[ ] Relabeling [ ] Modification/Adjustment
[ ] Other

10. [X] Additional Manufacturer Narrative and/or 11. [X] Corrected Data
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