BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX ACCESS ADV POS KIT

    MDR report key: 8479022 · Received April 3, 2019

    Report

    Report Number
    1643264-2019-00245
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 15, 2019
    Report Date
    May 27, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KQZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE PROVIDED IMAGE DID NOT PROVIDE ENOUGH DETAIL TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE ARM WAS WRAPPED AND BEING HELD BY THE PHYSICIANS ASSISTANT, IT DID NOT HOLD THE ARM. THE PHYSICIANS ASSISTANT HAD JUST CONNECTED PATIENTS WRAPPED ARM TO THE ACCESS TOWER, AND WHEN THE WEIGHTS WERE APPLIED TO PULL TRACTION, THE PATIENT BRACE WAS PULLED OFF THE PATIENT'S FOREARM. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271498 ACUFEX ACCESS ADV POS KIT COMPONENT, TRACTION, NON-INVASIVE KQZ SMITH & NEPHEW, INC. 50766949

    Patients

    Seq Age Sex Outcome Treatment
    1