MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 9.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number	66000709
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, customer has had a cyst excised and drained from her back, nurse applied opsite dressing which did not stay on and was lifting around the edges almost straight away.Customer then went to local chemist to have the dressing replaced with the same type of s&n opsite post op dressing and is having the same problem with the dressing not sticking.Customer is very concerned as she has an open wound on her back and can't see her doctor for re-dressing until the morning.The customer also advised that she experienced the same issue 6 weeks ago with this dressing from the initial surgery.It is unknown how was the procedure finished and if there was a delay.No other complications were reported.
Additional Manufacturer Narrative
The device 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.It was reported that the dressing was not sticking.Factors that can contribute to the reported event include skin preparation and application, the ifu offers further guidance.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 9.5X8.5CM CTN 20
• Common Device Name: 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: 11671074
• Report Number: 8043484-2021-00841
• Device Sequence Number: 11637630
• Product Code: KGX
• UDI-Device Identifier: 05000223441241
• UDI-Public: 05000223441241
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66000709
• Device Catalogue Number: 66000709
• Device Lot Number: 203351-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1