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

Model Number	66020626
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that while applying the 4th layer of two (2) profore kit latex free, the last quarter of the roll becomes very hard to unroll, it seems glued/melted together, so that they can not apply it to the patients leg, the nurse had to cut the last quarter off.Treatment was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection reported no defects.The functional evaluation found the roll is difficult unroll, establishing a relationship between the device and the reported event.The root cause was identified as manufacturing process issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint history review has found other related events, with corrective action implemented related to the reported event.Smith + nephew will continue to monitor for adverse trends.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation, confirming the reported event visual inspection noted no obvious defects, functional evaluation confirmed the profore layer 4 was difficult to unwind.A documentation investigation has been conducted, confirming previous complaints of this nature, with corrective actions assigned, establishing an inadequate standard operating procedure as the root cause.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 KIT LFF 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: 12443129
• Report Number: 8043484-2021-01762
• Device Sequence Number: 17432389
• Product Code: FQM
• UDI-Device Identifier: 05031844013883
• UDI-Public: 05031844013883
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2022

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: 01/01/2024
• Device Model Number: 66020626
• Device Catalogue Number: 66020626
• Device Lot Number: 1244139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 01/25/2022
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/23/2021; 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown