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

Model Number	66000016
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, the black and white dots were found on the 4th layer of profore 18-25cm ankle circ.Case 8.Patient was concerned the safety of this profore 4th layer.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation, confirming the reported event.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 complained product was manufactured prior to this action being implemented.A probable root cause has been determined to be a manufacturing quality deficiency.The product risk files mitigate the reported issue with no updates required.This investigation is now complete, with no additional corrective actions deemed necessary.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: 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: 13865445
• Report Number: 8043484-2022-00109
• Device Sequence Number: 14631771
• Product Code: FQM
• 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): 06/01/2022

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: 04/01/2024
• Device Model Number: 66000016
• Device Catalogue Number: 66000016
• Device Lot Number: 1335884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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