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

Model Number	66000415
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during treatment with a box of profore lite system kit case 8.The dressing will not unwind from the roll.The individual layers were tightly glued to one another.It was unknown how the procedure was finished.Patient was not harmed.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Images have been supplied confirming individual layers were tightly glued to one another, establishing a relationship between the device and the reported event.The root cause was identified as a tension issue on unwinding the raw material bulk roll, during the manufacturing process.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.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.
Additional Manufacturer Narrative
Additional information: b4, d1, d4, h4.
Event or Problem Description
It was reported that, during treatment with a box of profore lite lf system kit case 8.The dressing will not unwind from the roll.The individual layers were tightly glued to one another.The treatment was completed with a smith and nephew back up device.Patient was not harmed.
Additional Manufacturer Narrative
H6: updated codes.H10: the device, used in treatment, has not been returned for evaluation.Photographic evidence has been provided, however, the image does not clearly show evidence of the reported event and we cannot confirm a relationship between the device and the reported event.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 confirmed further instances of this nature.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 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
• 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: 11882906
• Report Number: 8043484-2021-01223
• Device Sequence Number: 1387861
• Product Code: FQM
• UDI-Device Identifier: 05031844002498
• UDI-Public: 05031844002498
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 08/01/2022
• Device Model Number: 66000415
• Device Catalogue Number: 66000771
• Device Lot Number: 873847
• 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: 05/10/2021
• Supplement Date Received by Manufacturer: 05/31/2021; 09/10/2021; 11/11/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/02/2021; 09/16/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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