MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE KIT LFF CASE 8; BANDAGE, ELASTIC

Model Number	66020626
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during treatment, a profore kit latex free multi-layer compression bandaging system was not pulling apart like normal.Treatment was resumed, after a non-significant delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
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 LFF 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: 13014293
• Report Number: 8043484-2021-02024
• Device Sequence Number: 1727397
• Product Code: FQM
• UDI-Device Identifier: 05031844013883
• UDI-Public: 05031844013883
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• 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: 66020626
• Device Catalogue Number: 66020626
• Device Lot Number: 1326470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 01/23/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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