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

Model Number	66000771
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that profore lite lf system kit case 8 (brown outer bandage) was too tightly wound on the roll.This made it almost impossible to apply the bandage since it did not want to loosen from the roll.Treatment was finished with the same device although the dressing started to get stuck on itself.This lead to discomfort the patient.
Event or Problem Description
It was reported that profore lite lf system kit case 8 (brown outer bandage) was too tightly wound on the roll.This made it almost impossible to apply the bandage since it did not want to loosen from the roll.Treatment was finished with the same device although the dressing started to get stuck on itself which lead to patient discomfort.
Additional Manufacturer Narrative
H10: the device intended to be used 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 causes may include a manufacturing process or degradation issue.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of this nature, with corrective action implemented to prevent further recurrence of this nature.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 12288396
• Report Number: 8043484-2021-01658
• Device Sequence Number: 3635452
• Product Code: FQM
• UDI-Device Identifier: 05000223459154
• UDI-Public: 05000223459154
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 06/01/2023
• Device Model Number: 66000771
• Device Catalogue Number: 66000771
• Device Lot Number: 1117451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1