MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X10CM; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800270

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Skin Irritation (2076); Injury (2348)

Event Date 02/19/2020

Event Type  Injury  

Event Description

It was reported that after the use of an allevyn gentle border 10x10cm dressing, which was applied (b)(6) 2020, the patient developed redness and skin peeling.It is unknown what was done to resolve the redness and peeling.

Manufacturer Narrative

H10.H3, h6: the device, used in treatment, has not been returned for evaluation, nor photos of the event.We have been unable to confirm a relationship between the event and the device or identify a root cause on this occasion.A device history record review has not been possible as no lot number was provided.However, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported event has been reviewed, revealing further instances.A clinical review has taken place, however without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A risk management review reports, failure modes that lead to mechanical dermatoses and irritation / irritant contact dermatoses including but not limited to; poor removal technique, dressing applied to fragile / sensitive skin, increased adhesion - trauma on removal.Without supporting information this failure mode cannot be narrowed down any further.The ifu has been reviewed, containing adequate cautions and warnings regarding the use.Including that dressings should be inspected frequently and where the product is used on infected wounds, the infection should be inspected and treated as per local clinical protocol.This investigation is now complete with no further actions necessary, and at this time.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER 10X10CM
• 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: 9930757
• MDR Text Key: 186676839
• Report Number: 8043484-2020-00265
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention