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

Catalog Number 66801195

Device Problem Defective Device (2588)

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

Event Date 06/19/2020

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.A backup was available.No delay was reported.The sample will be returned for investigation.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device used in treatment has been returned and evaluated, establishing a relationship between the event reported.The visual inspection confirmed silicone remained on the carrier, the functional evaluation confirmed reduced adherence, the root cause confirmed as raw material issues.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 GENTLE2.5CMX5M
• 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: 10261852
• MDR Text Key: 199059789
• Report Number: 8043484-2020-01813
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801195
• Device Lot Number: 1346051917
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention