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

Catalog Number	66000415
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer notified us that it seems that the quality of layer 4 cohesive layer has been changed.Since a while, it is much harder to roll off the bandage from the roll, leading to a more complicated application.No harm or injury reported.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Potential root causes include, user issues, product failure.A review of the associated batch manufacturing records could not be carried out as no batch/lot number was provided.However, we have no reason to suspect that the product did not meet specifications at the time of manufacture.The complaint history review found further instances of the reported event in the past years.No further actions are deemed necessary at this stage.However, 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 SYSTEM KIT CASE 8
• Common Device Name: DRESSING, COMPRESSION
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10593851
• Report Number: 8043484-2020-02987
• Device Sequence Number: 19130737
• Product Code: MHW
• UDI-Device Identifier: 05000223496371
• UDI-Public: 5000223496371
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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 Catalogue Number: 66000415
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 01/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1