BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILIFT 200

    MDR report key: 7503895 · Received May 10, 2018

    Report

    Report Number
    3009481053-2018-00020
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 10, 2018
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM INCIDENT, DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. MANUFACTURER TRIED TO CONTACT MULTIPLE TIMES AND NO RESPONSE RECEIVED. NO CONFIRMATION ON ROOT CAUSE, INJURY TYPE , OR TREATMENT METHODS AND/OR CORRECTIVE ACTIONS TO PERFORM ON THE DEVICE.

    Description of Event or Problem · 1

    WHILE OPERATING THE MINILIFT, THE USER WAS INJURED ON THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346884 MINILIFT 200 MINILIFT FSA HANDICARE AB 401100334

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR