MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE 18-25CM ANKLE CIRC. CASE 8; GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	66000016
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer provided feedback stating that this batch of profore 18-25cm ankle circ.Case 8 that they recently ordered has issue.After further discussion, they complained that certain part of the 4th layer #4 flexible cohesive bandage layer, for the recent batch received, has stick and crumpled together.They had difficulty to stretch the layer when force is applied, the #4 layer loss its stretchable tension.They didn't replace the #4 layer but continue to use on patient.Although no harm was cause to patient.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation, all supplied information has been reviewed and the complaint cannot be confirmed.¿a documentation review has been conducted, consisting of device history, the manufacturing process and complaint history.Previous complaints of this nature have been identified with corrective actions assigned, the corrective action has established and inadequate standard operating procedure as the root cause.The complained product was manufactured prior to this action being implemented.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The product risk files mitigate the reported issue with no updates required.This investigation is now complete, with no additional corrective actions deemed necessary.The probable root cause is deemed to be a manufacturing quality issue.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: PROFORE 18-25CM ANKLE CIRC. CASE 8
• Common Device Name: GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
• 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: 13415375
• Report Number: 8043484-2022-00044
• Device Sequence Number: 5985929
• Product Code: NAB
• UDI-Device Identifier: 05031844000746
• UDI-Public: 05031844000746
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 66000016
• Device Catalogue Number: 66000016
• Device Lot Number: 1215468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2022
• Supplement Date Received by Manufacturer: 03/05/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown