MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE KIT ANKLE 18-25CM USA CASE 8; BANDAGE, ELASTIC

Model Number	66020016
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, upon inspection, three (3) profore kits appeared to be stretched and with holes.In addition, it seems to be difficult to unroll them.Treatment was completed using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, upon inspection, three (3) profore kits appeared to be stretched and with holes.In addition, it seems to be difficult to unroll them.Treatment was completed using a back-up device.No other complications were 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.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: PROFORE KIT ANKLE 18-25CM USA CASE 8
• Common Device Name: BANDAGE, ELASTIC
• 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: 13573328
• Report Number: 8043484-2022-00075
• Device Sequence Number: 14863908
• Product Code: FQM
• UDI-Device Identifier: 05000223411244
• UDI-Public: 05000223411244
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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 Model Number: 66020016
• Device Catalogue Number: 66020016
• Device Lot Number: 1361857
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown