BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFORE LITE SYSTEM KIT CASE 8

    MDR report key: 12760250 · Received November 7, 2021

    Report

    Report Number
    8043484-2021-01933
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 13, 2021
    Report Date
    January 27, 2022
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQM
    UDI-DI
    05031844002498
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION THE DEVICE WAS NOT RETURNED FOR EVALUATION. ALL SUPPLIED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO CONFIRM THE COMPLAINT. A DOCUMENTATION INVESTIGATION HAS BEEN CONDUCTED, CONFIRMING PREVIOUS COMPLAINTS OF THIS NATURE ESTABLISHING AN INADEQUATE STANDARD OPERATING PROCEDURE AS THE ROOT CAUSE WITH CORRECTIVE ACTIONS ASSIGNED. A REVIEW OF THE DEVICE HISTORY CONFIRMED THAT NO MANUFACTURING PROBLEMS HAD BEEN OBSERVED. THE COMPLAINED PRODUCT WAS RELEASED PRIOR TO THE INITIATION OF THE CORRECTIVE ACTION. THE INSTRUCTIONS FOR USE CONTAIN COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE. THE RISK FILES MITIGATE THE REPORTED ISSUE WITH NO UPDATES REQUIRED. SMITH AND NEPHEW CAN CONFIRM THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATIONS AND CONTINUE TO MONITOR FOR ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. THIS INVESTIGATION IS NOW COMPLETE, WITH NO ADDITIONAL CORRECTIVE ACTIONS DEEMED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BROWN BANDAGE OF A PROFORE LITE SYSTEM KIT CASE 8 LITE MULTI-LAYER COMPRESSION BANDAGE SYSTEM STICKS AND THE COMPRESSION PRESSURE CANNOT BE BUILT UP PROFESSIONALLY. THE DEVICE IS ALSO VERY WRINKLED AND CANNOT BE ROLLED OUT PROPERLY. TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BROWN BANDAGE OF THE PROFORE LITE SYSTEM KIT CASE 8 LITE MULTI-LAYER COMPRESSION BANDAGE SYSTEM IS CRUMPLED AND CANNOT BE UNROLLED PROPERLY. IT IS THEREFORE DIFFICULT TO GENERATE THE CORRECT PRESSURE DURING APPLICATION/USE. TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661224 PROFORE LITE SYSTEM KIT CASE 8 BANDAGE, ELASTIC FQM SMITH & NEPHEW MEDICAL LTD. 66000415 1192890 05031844002498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown