MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT; DRESSING, WOUND, OCCLUSIVE

Model Number	66800269
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during treatment, a allevyn gentle border 7.5x7.5cm int had an insect between the foam layer and the top film.This happened before use in patient.Treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10: the device, which was not used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.Visual inspection confirmed an insect between the pink film and the pad.A failed in-process inspection has been identified as the root cause.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file does not contain further instances of the reported event.Operators were made aware of this complaint and re-trained to the in-process inspection work instruction.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER 7.5X7.5CM INT
• Common Device Name: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12410387
• Report Number: 8043484-2021-01707
• Device Sequence Number: 17151367
• Product Code: NAD
• UDI-Device Identifier: 05000223463878
• UDI-Public: 05000223463878
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 66800269
• Device Catalogue Number: 66800269
• Device Lot Number: 202111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown