MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4628
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, the top plastic film of an opsite flexigrid 6x7cm ctn 100is difficult or even impossible to remove after the application of the opsite dressings, and often the dressing does not remain in place.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
We have now concluded our investigation into the reported complaint.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review, was performed for the product and event description, there have been similar instances reported in the past three years.The event did not occur during patient treatment or diagnosis.Samples of the product were returned and evaluated and were found to be as described in the complaint.This confirmed a relationship between the device and the event.It has not been possible however to establish the root cause of the issue.The investigation has been closed.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE FLEXIGRID 6X7CM CTN 100
• 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: 11493020
• Report Number: 8043484-2021-00606
• Device Sequence Number: 2980186
• Product Code: KGX
• UDI-Device Identifier: 05000223046286
• UDI-Public: 5000223046286
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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 Catalogue Number: 4628
• Device Lot Number: 2029
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1