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

Catalog Number 66801196

Device Problem Material Integrity Problem (2978)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, during set up for wound treatment, when the carrier was removed, much of the silicone adhesive of a opsite flexifix gentle 5cmx5m removed with the carrier and did not remain on the film, so it could not be used.Treatment was resumed, with a back-up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation, without a physical sample we cannot confirm the reported event the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the instructions for use.A documentation review has been conducted, confirming the device was released according to specifications, complaint history has recorded previous occurrences of this nature, with corrective action, currently under effectiveness review, the complained product was released prior to the actions being initiated.The instructions for use and risk files, mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no corrective actions deemed necessary.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 13053612
• MDR Text Key: 284634349
• Report Number: 8043484-2021-02029
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223480387
• UDI-Public: 5000223480387
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 1386132041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1