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

Catalog Number 66801196

Device Problem Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

It was reported that 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 backup was available.No delay was reported.The sample will be returned for investigation.

Manufacturer Narrative

H3, h6: the device intended to be used in treatment has been returned for evaluation, all provided photos and information has been reviewed helping us establish a relationship between the event reported.Visual inspection confirmed silicon remained on the carrier, functional evaluation confirmed reduced adherence, root cause confirmed 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.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: 10798783
• MDR Text Key: 214992568
• Report Number: 8043484-2020-03760
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111153333
• UDI-Public: 4582111153333
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/12/2021

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: 66801196
• Device Lot Number: 1337691905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1