MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE KIT LATEX FREE; BANDAGE, ELASTIC

Model Number PROFORE KIT LATEX FREE

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2020

Event Type  malfunction  

Event Description

It was reported that during set up the coband layer were found to stick together and very difficult to pull apart.The product was not used on the patient and a back-up was available to continue the treatment.There was no delay and no patient harm was reported.

Manufacturer Narrative

H3, h6: the device that was intended for use in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.A lot number was not provided a document review was not performed.A complaint history review found other related failures.Probable cause may be a manufacturing related issue.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.(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 and inadequate standard operating procedure as the root cause.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.Without a valid lot, serial number we cannot perform any additional investigations, but we will continue to monitor for adverse trends relating to this product range.Smith & nephew continue to control the release of batches/devices against manufacturing specifications as part of our approved quality management system.This investigation is now complete, with no additional corrective actions deemed necessary.

• Brand Name: PROFORE KIT LATEX FREE
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull 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: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10176293
• MDR Text Key: 195807596
• Report Number: 8043484-2020-00881
• Device Sequence Number: 1
• Product Code: FQM
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROFORE KIT LATEX FREE
• Device Catalogue Number: 66020626
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• 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