MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 10CMX5M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66801197

Device Problem Problem with Sterilization (1596)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

It was reported that when the opsite flexifix gentle 10cmx5m was taken out of the carton, it was confirmed there was a foreign substance between the adhesive film and the release film.The treatment was completed, without delay, using a s+n back-up device.No patient injuries and no other complications were reported.

Manufacturer Narrative

H3, h6: the device intended to be used in treatment has been returned and evaluated establishing a relationship with the reported event.The visual evaluation confirmed a foreign substance between the adhesive film and the release film.Root cause determined 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 no further instances.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 GENTLE 10CMX5M
• 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: 11963754
• MDR Text Key: 255061648
• Report Number: 8043484-2021-01395
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223480400
• UDI-Public: 5000223480400
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 66801197
• Device Lot Number: 1381742036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1