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

Catalog Number 66801196

Device Problems Loss of or Failure to Bond (1068); Material Disintegration (1177)

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

Event Date 08/19/2020

Event Type  malfunction  

Event Description

It was reported that the adhesive glue is peeling off and it is not sticking to the skin.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation.But we have been able to review the supplied photo, this shows the silicone remained on the carrier.This has established a relationship between the reported event, with the root cause identified as a raw material issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture, the complaint history file contains further instances of the reported event.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: OPSITE FLEXIFIX GENTLE 5CMX5M
• 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: 10525361
• MDR Text Key: 206706755
• Report Number: 8043484-2020-02856
• 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: company representative,foreig
• 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 Expiration Date: 01/01/2021
• Device Catalogue Number: 66801196
• Device Lot Number: 1336151903
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1