MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 25X10CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number	66000714
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint: (b)(4).
Event or Problem Description
It was reported that during treatment, when opening the opsite post op dressing, it was observed that the dressing was with the gauze without adhering to the film.It is unknown how the treatment was completed.No patient harm or delay reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.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 reported event or determine a root cause on this occasion.Potential factors that can contribute to the reported event include the film raw material quality 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 event, however this investigation is now complete with no further action deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.(b)(4).

• Brand Name: OPSITE POST OP 25X10CM 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: 10984522
• Report Number: 8043484-2020-04150
• Device Sequence Number: 16940541
• Product Code: KGX
• UDI-Device Identifier: 05000223441395
• UDI-Public: 05000223441395
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 66000714
• Device Catalogue Number: 66000714
• Device Lot Number: 201946
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1