MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE 18-25CM ANKLE CIRC. CASE 8; BANDAGE, ELASTIC

Catalog Number 66000016

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  malfunction  

Event Description

It was reported that during treatment the profore 18-25cm ankle circ.Case 8 light conformable bandage was no rolled neatly.The treatment finished with a smith and nephew backup device.No surgical delay.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirmed the rolls where not wound neatly, establishing a relationship between the device and the reported event.The root cause identified as a missed quality check.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 found further instances of the reported 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.

• Brand Name: PROFORE 18-25CM ANKLE CIRC. 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 ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 10505105
• MDR Text Key: 206088729
• Report Number: 8043484-2020-02774
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 05000223415129
• UDI-Public: 5000223415129
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 66000016
• Device Lot Number: 966503
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• 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