MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PROFORE LITE; BANDAGE, ELASTIC

Catalog Number 66801270

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2020

Event Type  malfunction  

Event Description

It was reported that during treatment the brown bandage of profore lite cannot be unwound at the end.Procedure was completed with the same product and no harm or injury reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation, nor any photos to show the alleged issue.We have been unable to establish a relationship between the reported event and the device or determine a root cause on this occasion.If the device is returned in the future, this complaint will be re-assessed.It was noted that treatment was continued using the product, with no further reported issues.As no control sample has been returned we are unable to fully investigate this complaint, therefore we are unable to provide probable causes as to why these events happened, however it is noted historically there has been issue where the bandages has been rolled too tight, presenting difficulty upon use.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing further instances.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN PROFORE LITE
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10209907
• MDR Text Key: 196930293
• Report Number: 8043484-2020-01158
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801270
• Device Lot Number: 873847
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 66000771 PROFORE LITE LF SYSTEM KIT CASE 8