MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN GENTLE (GENERATION II); DRESSING, WOUND, OCCLUSIVE

Lot Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2020

Event Type  malfunction  

Event Description

It was reported that on removal of the plastic cover of two new allevyn gentle border dressings, part of the silicone came away from the foam and remained on the plastic cover.Additionally, on removal of an allevyn gentle heel placed on the patient's skin to treat pressure ulcer, bits of silicone remained on the skin and had to be picked off.It is unknown if a back-up was available and if there was a delay in the procedure.No patient harm reported.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.The device used in treatment has not been returned for evaluation.The photo provided confirms a relationship between the device and the reported event.Silicone remained on the carrier paper reducing adhesion.A raw material issue has been identified as the root cause.No batch 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 file contains further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.However, this investigation is now complete with no further action deemed necessary at this stage.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKNOWN ALLEVYN GENTLE (GENERATION II)
• 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: 10246381
• MDR Text Key: 198098455
• Report Number: 8043484-2020-01765
• Device Sequence Number: 1
• Product Code: NAD
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1