MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 5CM X 1M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 36361379

Device Problem Defective Component (2292)

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

Event Date 05/27/2021

Event Type  malfunction  

Event Description

It was reported that, during treatment with opsite flexifix gentle 5cm x 1m, the customer bought the dressing and the adhesives got stuck and remained on the plastic backing.It is unknown how treatment was resumed.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device used in treatment has been returned and evaluated, establishing a relationship between the event reported.Visual inspection confirmed the adhesive was stuck and remained on the plastic backing.Root caused determined as component failure.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.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 5CM X 1M
• 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: 11995537
• MDR Text Key: 256076704
• Report Number: 8043484-2021-01459
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 09330169004610
• UDI-Public: 9330169004610
• 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: 06/25/2021

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: 36361379
• Device Lot Number: 1357451929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1