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

Model Number PROFORE KIT LATEX FREE

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

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, intended for use, in treatment was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.This investigation has not been able to determine a definitive root cause, however factors that can contribute to the reported issues are temperature fluctuation during transport and storage.If the material is subject to temperature fluctuations then this can affect the use.No batch/lot number has been provided, therefore a review of the device history has not been possible.A complaint history review found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

Section: h3, h6: the device, used in treatment, has not been returned for evaluation.The information provided has been reviewed and we cannot confirm a relationship between the device and the reported event.No lot/serial number has been provided, therefore a review of device history is not possible.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.A complaint history review was performed for the product and event description, there have been further instances of this nature.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.H6: health effect, medical device problem, investigation findings and investigation conclusion.

• 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 HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10176303
• MDR Text Key: 195921244
• Report Number: 8043484-2020-00884
• 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: 11/16/2021

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: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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