MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE2.5CMX5M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66801195

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

It was reported that in a opsite flexifix gentle 2.5cm x 5m roll, when the carrier was removed, much of the silicone adhesive was removed with the carrier and did not remain on the film, so it could not be used.A smith and nephew backup was available.No delay was reported.

Manufacturer Narrative

The device intended to be used in treatment has been returned for evaluation, all provided information has been reviewed, establishing a relationship between the event reported.Visual inspection confirmed silicone remained on the carrier, functional evaluation confirmed reduced adherence, root cause established as raw material issue.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture, complaint history review found other related events.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.G1 mdr reporting contact name and address.

• Brand Name: OPSITE FLEXIFIX GENTLE2.5CMX5M
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10813014
• MDR Text Key: 215459999
• Report Number: 8043484-2020-03791
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111153326
• UDI-Public: 4582111153326
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801195
• Device Lot Number: 1366321949
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1