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

Model Number	66000771
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the brown cohesive roll cannot be unwound and is severely stuck together.It is unknown when did the event occurred and if there was a patient involvement.No other complications where reported.
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 device and the reported event or determine a root cause.Probable root cause is storage temperature, which can affect use.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: PROFORE LITE LF 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
• MDR Report Key: 11384798
• Report Number: 8043484-2021-00422
• Device Sequence Number: 3786714
• Product Code: FQM
• UDI-Device Identifier: 05000223459154
• UDI-Public: 05000223459154
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Model Number: 66000771
• Device Catalogue Number: 66000771
• Device Lot Number: 1108345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1