MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 10CMX5M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66801197

Device Problems Nonstandard Device (1420); Difficult to Remove (1528)

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

Event Date 07/28/2021

Event Type  malfunction  

Event Description

It was reported that, during set up, when the carrier was removed from opsite flexifix gentle 10 cm x 5 m, much of the silicone adhesive did not remain on the film and got removed with the carrier from the film.Some parts of the roll could be used for treatment, however silicone adhesive residue remained on the skin when it was removed.Treatment was completed using a smith and nephew back up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

The device, 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 10CMX5M
• 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: 12316438
• MDR Text Key: 266386958
• Report Number: 8043484-2021-01676
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223480400
• UDI-Public: 5000223480400
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801197
• Device Lot Number: 132932047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2021
• 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