MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 6.5X5CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66000708

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/09/2021

Event Type  malfunction  

Event Description

It was reported that, during the set up of a wound dressing treatment, an opsite post op 6.5x5cm ctn 100 had a foreign substance on the pad, so it was not used.This happened before use in patient.The treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.

Manufacturer Narrative

The device, intended to be used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.The returned sample was torn open and the foreign body was found interwoven in the pad, with the root cause was identified as a raw material issue.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 of the reported events.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST OP 6.5X5CM CTN 100
• 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: 12049993
• MDR Text Key: 257762734
• Report Number: 8043484-2021-01549
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223441227
• UDI-Public: 5000223441227
• 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
• Report Date: 07/13/2021

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 Catalogue Number: 66000708
• Device Lot Number: 202012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1