MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66800269

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that on removal of the plastic cover of the dressing, part of the silicone came away from the foam and remained on the plastic cover.Additionally, on removal of the same type of dressing from the patients skin, 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, intended to be used in treatment, was returned for evaluation.Visual inspection and functional evaluation confirmed a relationship between the event and the device.The silicone remained on the carrier paper reducing adhesion.A raw material issue has been identified as the root cause.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history file contains further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER 7.5X7.5CM INT
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10192591
• MDR Text Key: 196446979
• Report Number: 8043484-2020-00944
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800269
• Device Lot Number: 202002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1