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

Catalog Number	66000016
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, fourth layer of profore 18-25cm ankle circ is not rolling out or malformed (shredded).A backup device was used.Information of the patient is unknown.
Additional 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.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.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.

• Brand Name: PROFORE 18-25CM ANKLE CIRC. CASE 8
• Common Device Name: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10426094
• Report Number: 8043484-2020-02542
• Device Sequence Number: 3122215
• Product Code: FQM
• UDI-Device Identifier: 05000223415129
• UDI-Public: 5000223415129
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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 Catalogue Number: 66000016
• Device Lot Number: 162738
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1