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

Catalog Number	4628
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that when replacing the film for the patient, it was difficult to tear off the protective paper after the film applied to the skin.The procedure was able to be completed with the same device.Surgery was not delayed.No harm or injury reported.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.A difficult to setup or prepare device would not be likely to cause or contribute to a death or serious injury.Event may result in minor or temporary injury (e.G., pain) requiring no or minor medical intervention.The event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §80.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13715782
• Report Number: 8043484-2022-00097
• Device Sequence Number: 6286925
• Product Code: KGX
• UDI-Device Identifier: 05000223046286
• UDI-Public: 5000223046286
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 2007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female