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	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, customer used 1 out of the box and found that it was not sticking to her skin.The customer had clean skin with no moisturising products on the skin prior to application.No delay was reported.It is unknown how the procedure was finished.No other complications where reported.
Additional Manufacturer Narrative
The device used in treatment has not been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the device and the event reported or determine a root cause on this occasion.It was reported that the dressing was not sticking to skin.Potential 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: 11547848
• Report Number: 8043484-2021-00662
• Device Sequence Number: 3815285
• Product Code: KGX
• UDI-Device Identifier: 05000223441241
• UDI-Public: 05000223441241
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: Lay User/Patient
• Device Expiration Date: 04/01/2025
• Device Model Number: 66000709
• Device Catalogue Number: 66000709
• Device Lot Number: 202016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1