MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 15X28CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Model Number	4986
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	11/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the dr.Informed that lately the quality of the opsite incise is not good since it is not sticking properly to the skin at the moment of surgery.It comes out of the skin.It is unknown how the procedure was completed or if there was a delay.No patient harm reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.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 reported event or determine a root cause on this occasion.Possible causes could include a raw material, or skin preparation issue, the instructions for use provide comprehensive instructions of the safe operation, use and limitations of the device.Medical review concluded without the requested information a review could not be rendered.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE INCISE 15X28CM CTN 10
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11039867
• Report Number: 8043484-2020-04327
• Device Sequence Number: 1023811
• Product Code: KGX
• UDI-Device Identifier: 05000223415495
• UDI-Public: 05000223415495
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2021

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: 4986
• Device Catalogue Number: 4986
• Device Lot Number: 201915
• Initial Date Received by Manufacturer: 11/28/2020
• Supplement Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1