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Field Safety Notice

This field safety notice from Ammar Optician Company concerns one of their medical device products. It provides information on the affected devices, the reason for the field safety corrective action, and the type of action to be taken to mitigate the risk. This includes identifying the device, quarantining it, and returning it to the manufacturer. Customers are required to reply with confirmation that the action has been taken. The manufacturer will also take action such as product removal or an instruction for use change. Completion of these actions is required by a specified date.

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Mohamed Ezzat
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422 views3 pages

Field Safety Notice

This field safety notice from Ammar Optician Company concerns one of their medical device products. It provides information on the affected devices, the reason for the field safety corrective action, and the type of action to be taken to mitigate the risk. This includes identifying the device, quarantining it, and returning it to the manufacturer. Customers are required to reply with confirmation that the action has been taken. The manufacturer will also take action such as product removal or an instruction for use change. Completion of these actions is required by a specified date.

Uploaded by

Mohamed Ezzat
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Field Safety Notice

Ammar Optician Company


Medical Devices & Equipment Section
EMAIL: [email protected]

TELEPHONE: 17593001

1. Information on Affected Devices*


1 1. Device Type(s)*
.

1 2. Commercial name(s)
.

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


.
1 4. Primary clinical purpose of device(s)*
.

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


.
1 6. Software version
.

1 7. Affected serial or lot number range


.
1 8. Associated devices
.

2 Reason for Field Safety Corrective Action (FSCA)*


2 1. Description of the product problem*
.
2 2. Hazard giving rise to the FSCA*
.

2 3. Probability of problem arising


.
2 4. Predicted risk to patient/users
.
5. Further information to help characterise the problem
2
.

2 6. Background on Issue
.
2 7. Other information relevant to FSCA
.

3. Type of Action to mitigate the risk*


3 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
3 2. By when should the action
. be completed?

3 3. Particular considerations for: Choose an item.


.
Is follow-up of patients or review of patients’ previous results recommended?
Choose an item.

3 4. Is customer Reply Required? * Choose an item.


. (If yes, form attached specifying deadline for return)

3 5. Action Being Taken by the Manufacturer


.
☐ Product Removal ☐ On-site device modification/inspection
☐ Software upgrade ☐ IFU or labelling change
☐ Other ☐ Non
Provide further details of the action(s) identified.

3 6. By when should the action


be completed?
3 7. Is the FSN required to be communicated to the patient Choose an item.
. /lay user?

3 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*
4 1. FSN Type* Choose an item.
.

4 2. For updated FSN, reference


. number and date of previous FSN

4 3. For Updated FSN, key new information as follows:


.

4 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:

4
6. Anticipated timescale for follow-up
FSN
4
4 7. Manufacturer information
. (For contact details of local representative refer to page 1 of this FSN )
a. Company Name

b. Address
c. Website address

4 8. The Competent (Regulatory) Authority of your country has been informed about this
. communication to customers. *

4 9. List of attachments/appendices:
.

4 10. Name/Signature
.

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