MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 15.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number	66000712
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up or inspection, it was noticed that the adhesive of opsite post op dressings was weak so the release paper was separated, and the film part was sticking to the wrapping paper.From (b)(4): 3 dressings presented the failure mode.(b)(4): customer said that dressings had the reported problem and those were already discarded.No case involved; therefore, no patient involvement.
Additional Manufacturer Narrative
The device intended to be 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 release paper was separated.Factors that can contribute to the reported event include the worn anti-adhesive roller.The manufacturing records show no evidence that the product did not meet the 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 at this stage.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST OP 15.5X8.5CM 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: 11580349
• Report Number: 8043484-2021-00685
• Device Sequence Number: 4882388
• Product Code: KGX
• UDI-Device Identifier: 05000223441333
• UDI-Public: 05000223441333
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 66000712
• Device Catalogue Number: 66000712
• Device Lot Number: 201945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1