MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE2.5CMX5M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66801195

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 07/30/2021

Event Type  malfunction  

Event Description

It was reported that, when the carrier of two (2) opsite flexifix gentle 2.5 cm x 5 m roll was withdrawn, much of the silicone adhesive was removed with the carrier and did not remain on the film.Treatment was resumed, without any delay, with a competitor's back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.The visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed reduced adherence, establishing a relationship between the device and the reported event.The root cause was identified as a component failure.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: OPSITE FLEXIFIX GENTLE2.5CMX5M
• 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: 12321136
• MDR Text Key: 266660150
• Report Number: 8043484-2021-01682
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223480363
• UDI-Public: 5000223480363
• 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: 09/14/2021

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: 66801195
• Device Lot Number: 1369882011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• 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