MAUDE Adverse Event Report: 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 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the adhesive substance of a opsite flexifix gentle2.5cmx5m separates from the silicone strip.As this happened in a non-therapeutic environment, there was not patient involvement.

Manufacturer Narrative

H10: the device, intended for use 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 device and the reported event or determine a root cause.A potential root cause may include a component failure as the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the ifu.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review has found other similar events, with corrective action initiated in relation to the reported failure mode.Smith + nephew will continue to monitor for adverse trends.H6: updated codes.

• Brand Name: OPSITE FLEXIFIX GENTLE2.5CMX5M
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 12565090
• MDR Text Key: 274458683
• Report Number: 8043484-2021-01831
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223480363
• UDI-Public: 5000223480363
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 66801195
• Device Lot Number: 1386122045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2021
• Date Device Manufactured: 11/01/2020
• 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