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

Catalog Number 66801195

Device Problem Material Separation (1562)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device intended to be used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the product and reported event, or determine a root cause.Probable root cause may be due to component failure, the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the ifu.No lot/serial number has been provided, therefore a review of device history is not possible.A complaint history review has found other related events, with corrective action implemented related to the reported event.Smith + nephew will continue to monitor for adverse trends.

Event Description

It was reported that, during set-up/inspection of wound treatment, when the carrier was withdrawn, much of the silicone adhesive of (2) opsite flexifix gentle 2.5cm x 5m rolls removed with the carrier and did not remain on the film.Treatment was performed, without any delay, with a smith & nephew back-up device instead.Patient was not injured as consequence of this problem.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12747181
• MDR Text Key: 279954699
• Report Number: 8043484-2021-01926
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223480363
• UDI-Public: 5000223480363
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2021

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: 66801195
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1