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

Catalog Number 66801196

Device Problem Defective Device (2588)

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

Event Date 05/07/2020

Event Type  malfunction  

Event Description

It was reported that when the carrier was removed, the silicone adhesive did not remain on the film and removed with the carrier from the film, so it was impossible to use.Backup opsite flexifix gentle was used for treatment.No delay was reported.The sample will be returned for investigation.

Manufacturer Narrative

H3, h6: the device intended for use in treatment has been returned and evaluated establishing a relationship between the reported event.The evaluation confirmed silicone remained on the carrier reducing adherence.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 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10115871
• MDR Text Key: 193719411
• Report Number: 8043484-2020-00620
• 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: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Catalogue Number: 66801196
• Device Lot Number: 1353001931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Distributor Facility Aware Date: 05/07/2020
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1