MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST-OP VISIBLE 35X10CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number	66800141
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during set up the package was found defective.It is unknown what happened to the package.Treatment was started with the competitors product.No patient harm was reported.
Additional Manufacturer Narrative
We have now concluded our investigation into the complaint reported.The device intended to be used in treatment has been returned and evaluated establishing a relationship with the reported event.The visual inspection confirmed that one side of the device was not sealed, a failed in-process inspection has been identified as the root cause.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.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.Since no patient injuries were reported, no further clinical/medical assessment is warranted.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.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 VISIBLE 35X10CM 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: 11157082
• Report Number: 8043484-2021-00090
• Device Sequence Number: 10929348
• Product Code: KGX
• UDI-Device Identifier: 05000223468637
• UDI-Public: 05000223468637
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 66800141
• Device Catalogue Number: 66800141
• Device Lot Number: 202008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 04/10/2021
• Initial Report FDA Received Date: 01/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention