MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE LITE SYSTEM KIT CASE 8; BANDAGE, ELASTIC

Model Number	66000415
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the brown bandage of a profore lite system kit case 8 lite multi-layer compression bandage system sticks and the compression pressure cannot be built up professionally.The device is also very wrinkled and cannot be rolled out properly.Treatment was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that the brown bandage of the profore lite system kit case 8 lite multi-layer compression bandage system is crumpled and cannot be unrolled properly.It is therefore difficult to generate the correct pressure during application/use.Treatment was performed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: additional information the device was not returned for evaluation.All supplied information has been reviewed and we have not been able to confirm the complaint.A documentation investigation has been conducted, confirming previous complaints of this nature establishing an inadequate standard operating procedure as the root cause with corrective actions assigned.A review of the device history confirmed that no manufacturing problems had been observed.The complained product was released prior to the initiation of the corrective action.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.

• Brand Name: PROFORE LITE SYSTEM KIT 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: 12760250
• Report Number: 8043484-2021-01933
• Device Sequence Number: 19888086
• Product Code: FQM
• UDI-Device Identifier: 05031844002498
• UDI-Public: 05031844002498
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: 66000415
• Device Catalogue Number: 66000415
• Device Lot Number: 1192890
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/27/2022
• 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