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

Model Number	66000415
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Failure to Unfold or Unwrap (1669); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference number: (b)(4).
Event or Problem Description
It was reported that a the #4 roll of profore lite system kit case 8 lite multi-layer compression bandage system could not be unrolled like normal it had strong adhesions.It is unknown whether this problem was noticed in a therapeutic environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
H10: the device has not been returned for evaluation, it is unknown if it was used in treatment.The information provided has been reviewed and we cannot confirm a relationship between the device and the reported event.A review of the manufacturing records confirmed the device was released according to specification, complaint history review found further instances.A review of the manufacturing process was performed, and a root cause of inadequate standard operating procedure has been determined.Corrective action has been initiated regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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 78735 ; 5123913905
• MDR Report Key: 12751382
• Report Number: 8043484-2021-01927
• Device Sequence Number: 4921146
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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 Expiration Date: 02/01/2024
• Device Model Number: 66000415
• Device Catalogue Number: 66000415
• Device Lot Number: 1278042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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