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

Model Number	66020016
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the 4th layer of a box of profore multi-layer high compression bandaging system does not come off of the roll very easily.It appears that the layers are sticking to each other.As this was noticed in a non-surgical environment, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.All supplied information has been reviewed and we have not been able to confirm the complaint.A documentation review has been conducted, confirming previous complaints of this nature, with corrective actions assigned, which established an inadequate standard operating procedure as the root cause.The complained product was released prior to the actions being initiated.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete, with no additional corrective actions deemed necessary.

• 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: 13111173
• Report Number: 8043484-2021-02066
• Device Sequence Number: 14241683
• Product Code: FQM
• UDI-Device Identifier: 05000223411244
• UDI-Public: 05000223411244
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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 Expiration Date: 03/01/2024
• Device Model Number: 66020016
• Device Catalogue Number: 66020016
• Device Lot Number: 1278053
• 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: 12/09/2021
• Supplement Date Received by Manufacturer: 01/23/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2021
• 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