MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10 X 10CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800270

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that 3 x patients have had a reaction to the allevyn gentle border adhesive and developed a rash under the silicone.The rash was widespread and all over where the adhesiveness is.No other symptoms.The allevyn gentle border was removed and a new alternate dressing applied with the reaction resolved.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable causes are application, removal, time left on patient, trauma, materials used within the dressing.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.Therefore, based on insufficient information it cannot be definitively concluded that the root cause of the reported rash is the direct result of using the allevyn dressing.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains further instances.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 10 X 10CM CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11158753
• MDR Text Key: 226536931
• Report Number: 8043484-2021-00101
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223463922
• UDI-Public: 05000223463922
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800270
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention