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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Localized Skin Lesion (4542)

Event Date 02/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient keeps reacting to the adhesive edge of allevyn gentle broder.A new wound was created due to this.It is unknown how the wounds were treated.

Manufacturer Narrative

H10, h3, h6: the device that was used in treatment was not returned for evaluation, although photos were provided we could establish a relationship between the reported event, however a root cause could not be determined at this time, probable root cause may include application technique or a skin reaction from the allevyn product.A dhr review could not be performed because the lot number was not provided.A complaint history review found other related failures.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The associated risk files contain the reported failure/harm or event.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: UNKN ALLEVYN GENTLE BORDER
• Type of Device: 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: 11467607
• MDR Text Key: 239361717
• Report Number: 8043484-2021-00532
• 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: 06/10/2021

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
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention