MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 10CM X 1M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 36361380

Device Problems Loss of or Failure to Bond (1068); Physical Resistance/Sticking (4012)

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

Event Date 05/22/2021

Event Type  malfunction  

Event Description

It was reported that, during treatment, a opsite flexifix gentle 10cm x 1m was leaving residue on plastic backing and then was not sticking to skin.It is unknown how the treatment was completed, patient was not harmed as a consequence of this problem.

Event Description

It was reported that, during treatment, a opsite flexifix gentle 10cm x 1m was leaving residue on plastic backing and then was not sticking to skin.Treatment was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.

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 device and the reported event or determine a root cause, probable root cause may include, component failure, 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 found further instances of the reported event.A complaint history review has found other related events, smith + nephew have implemented corrective action relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: OPSITE FLEXIFIX GENTLE 10CM X 1M
• 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
• MDR Report Key: 12134795
• MDR Text Key: 260471960
• Report Number: 8043484-2021-01644
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 09330169004627
• UDI-Public: 9330169004627
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

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: 03/01/2022
• Device Catalogue Number: 36361380
• Device Lot Number: 1370472011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/11/2021; 10/19/2021
• Supplement Dates FDA Received: 07/28/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1