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

Model Number 66020626

Device Problems Difficult to Fold, Unfold or Collapse (1254); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Internal complaint reference: (b)(4).

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
• Type of Device: 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
• MDR Text Key: 282558531
• Report Number: 8043484-2021-02024
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 05031844013883
• UDI-Public: 05031844013883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1