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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one patient in a short time who had allevyn gentle border dressing reacted to the dressing.This patient got a red skin rash in the area alongside the border of allevyn gentle.They used cortisone and replaced with mepilex border dressing.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.No batch/lot number has been provided, however, at this time, we have no reason to suspect that the product did not meet specifications at the time of manufacture.The complaint history review found further instances of the reported event in the past years.Clinical review concluded: although requested no photos were provided for review.The causal relationship between the s+n device and the reported issue cannot be confirmed based on the information provided.Factors that are known to contribute to the alleged fault/failure may be a raw material failure or an allergic reaction.The associated risk files contain details relating to harm.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.This investigation is now complete with no further action deemed necessary.Smith + 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
• MDR Report Key: 10603524
• Report Number: 8043484-2020-03039
• Device Sequence Number: 2555460
• Product Code: NAD
• UDI-Device Identifier: 05000223463878
• UDI-Public: 05000223463878
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 66800269
• Device Catalogue Number: 66800269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention