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

Catalog Number 66801196

Device Problem Nonstandard Device (1420)

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

Event Date 08/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported, that when the carrier was removed of a opsite flexifix gentle 5cm x 5m roll much of the silicone adhesive was removed with the carrier and did not remain on the film.Incident occurred during set up or inspection; therefore, there was no patient involvement.

Manufacturer Narrative

The device ,intended to be used in treatment, was returned for evaluation.A visual inspection reported silicone remained on the carrier.The functional evaluation confirmed reduced adherence, establishing a relationship between the device and the reported event.The root cause has been determined as a component failure, the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the ifu.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.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.

• 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 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: 12494777
• MDR Text Key: 272126485
• Report Number: 8043484-2021-01779
• 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: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

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 Expiration Date: 03/27/2022
• Device Catalogue Number: 66801196
• Device Lot Number: 1370442010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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