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

Model Number 66020626

Device Problems Material Puncture/Hole (1504); Material Separation (1562); Defective Component (2292)

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

Event Date 08/09/2021

Event Type  malfunction  

Event Description

It was reported that, while using profore kit lff case 8 compression system, the coban layer had holes, the bottom was falling apart and near the end it looked extremely dirty.It is unknown how the treatment was finished.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Photographic evidence has been provided, however, the image does not clearly show evidence of the reported event and we cannot confirm a relationship between the device and the reported event.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture, a complaint history review confirmed further instances of this nature.A review of the manufacturing process was performed, and a root cause of inadequate standard operating procedure has been assigned.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 12355523
• MDR Text Key: 267735843
• Report Number: 8043484-2021-01691
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 66020626
• Device Catalogue Number: 66020626
• Device Lot Number: 1215479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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