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

Catalog Number 66801195

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

It was reported that during set up and inspection when the opsite 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; the procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The device was not used in treatment hasn't been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the reported event or determine a root cause on this occasion.Probable root cause include, raw material issue, the ifu offers further guidance.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.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE FLEXIFIX GENTLE2.5CMX5M
• 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: 10687323
• MDR Text Key: 211620382
• Report Number: 8043484-2020-03221
• 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: 05/13/2021

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: 11/19/2020
• Device Catalogue Number: 66801195
• Device Lot Number: 1325571846
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1