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

Model Number 66020016

Device Problem Failure to Unfold or Unwrap (1669)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reporter that, ten (10) profore kit ankle 18-25cm usa case 8 seems to be sticking to itself and looping causing it to be very difficult to impossible to get a accurate compression.As this happened in a non-surgical environment, there was not patient involvement.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation, images have been provided confirming the reported event.Evaluation of the supplied images confirms the reported event, the images clearly show the coband layer sticking together, which would cause difficulty in application ¿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.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete, with no additional corrective actions deemed necessary.

Event Description

It was reporter that profore kit ankle 18-25cm usa case 8 seems to be sticking to itself and looping causing it to be very difficult to impossible to get a accurate compression.As this happened in a non-surgical environment, there was not patient involvement.

• Brand Name: PROFORE KIT ANKLE 18-25CM USA 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: 12968028
• MDR Text Key: 284873219
• Report Number: 8043484-2021-02002
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 05000223411244
• UDI-Public: 05000223411244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: 66020016
• Device Catalogue Number: 66020016
• Device Lot Number: 1278048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2021
• 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