FSN Form - V1

Reference.
FSN001-2021
Date: / /
Agent Ref.
Manufacturer ref.
Urgent Field Safety Notice

***Device commercial name***
For Attention of*:Health care professional / Pharmacies.
Contact details of local representative:
Name: Ashraf Mahmoud Mohamed

Email: ashraf.mahmoud19742018@gmail.com
Tel. +973-34243432
We are the distributer of………………. Agent is ………………………origin…………………
Page 1 of 6
Reference. FSN001-2021
Urgent Field Safety Notice (FSN)

Device Commercial Name
Risk addressed by FSN
1. Information on Affected Devices*

1. Device Type(s)*
2. Commercial name(s)
3. Unique Device Identifier(s) (UDI-DI)
4. Primary clinical purpose of device(s)*
5. Device Model/Catalogue/part number(s)*
6. Software version
7. Affected serial or lot number range
8. Associated devices
Page 2 of 6
2 Reason for Field Safety Corrective Action (FSCA)*

1. Description of the product problem*
2. Hazard giving rise to the FSCA*
3. Probability of problem arising
4. Predicted risk to patient/users
5. Further information to help characterise the problem
6. Background on Issue
7. Other information relevant to FSCA
Page 3 of 6
3. Type of Action to mitigate the risk*

1. Action to Be Taken by the User*
☐ Identify Device ☐ Quarantine Device ☐ Return Device ☐ Destroy Device
☐ On-site device modification/inspection
☐ Follow patient management recommendations
☐ Take note of amendment/reinforcement of Instructions for Use (IFU
☐ Other ☐ None
Provide further details of the action(s) identified.
2. By when should the Specify where critical to patient/end user safety

action be completed?
3. Particular considerations for: Choose an item.
Is follow-up of patients or review of patients’ previous results recommended?

Choose an item.
Provide further details of patient-level follow-up if required or a justification why none is required
4. Is customer Reply Required? * Choose an item.
(If yes, form attached specifying deadline for return)
5. Action Being Taken by the Manufacturer
☐ Product Removal ☐ On-site device modification/inspection

☐ Software upgrade ☐ IFU or labelling change
☐ Other ☐ None
Provide further details of the action(s) identified.
Page 4 of 6
6. By when should the Specify where critical to patient/end user safety

action be completed?
7. Is the FSN required to be communicated to the patient Choose an item.
/lay user?
8. If yes, has manufacturer provided additional information suitable for the patient/lay
user in a patient/lay or non-professional user information letter/sheet?
Choose an item. Choose an item.
4. General Information*
1. FSN Type* Choose an item.
2. For updated FSN, reference

number and date of previous
FSN
3. For Updated FSN, key new information as follows:
4. Further advice or information Choose an item.

already expected in follow-up
FSN? *
5. If follow-up FSN expected, what is the further advice expected to relate to:
6. Anticipated timescale for follow-

up FSN
7. Manufacturer information
(For contact details of local representative refer to page 1 of this FSN)
a. Company Name
b. Address
c. Website address
Page 5 of 6
8. The Competent (Regulatory) - NHRA has been informed about this communication to
customers. *
9. List of attachments/appendices:
10. Name/Signature
Note: Fields indicated by * are considered necessary for all FSNs. Others are optional.
Transmission of this Field Safety Notice

This notice needs to be passed on all those who need to be aware within your organization or to any organization
where the potentially affected devices have been transferred. (As appropriate)
Please transfer this notice to other organizations on which this action has an impact. (As appropriate)
Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of
the corrective action.
Please report all device-related incidents to the manufacturer, distributor or local representative, and the national
Competent Authority if appropriate, as this provides important feedback. *
Page 6 of 6

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Reference.

Urgent Field Safety Notice

For Attention of*:Health care professional / Pharmacies.

Contact details of local representative:

Name: Ashraf Mahmoud Mohamed

We are the distributer of………………. Agent is ………………………origin…………………

Urgent Field Safety Notice (FSN)

1. Information on Affected Devices*

3. Unique Device Identifier(s) (UDI-DI)

4. Primary clinical purpose of device(s)*

5. Device Model/Catalogue/part number(s)*

7. Affected serial or lot number range

2 Reason for Field Safety Corrective Action (FSCA)*

2. Hazard giving rise to the FSCA*

3. Probability of problem arising

4. Predicted risk to patient/users

5. Further information to help characterise the problem

7. Other information relevant to FSCA

3. Type of Action to mitigate the risk*

☐ Identify Device ☐ Quarantine Device ☐ Return Device ☐ Destroy Device

☐ On-site device modification/inspection

☐ Follow patient management recommendations

☐ Take note of amendment/reinforcement of Instructions for Use (IFU

2. By when should the Specify where critical to patient/end user safety

3. Particular considerations for: Choose an item.

Is follow-up of patients or review of patients’ previous results recommended?

5. Action Being Taken by the Manufacturer

☐ Product Removal ☐ On-site device modification/inspection

Provide further details of the action(s) identified.

6. By when should the Specify where critical to patient/end user safety

2. For updated FSN, reference

4. Further advice or information Choose an item.

6. Anticipated timescale for follow-

Transmission of this Field Safety Notice

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