BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC MOBILITY

    MDR report key: 7644601 · Received June 28, 2018

    Report

    Report Number
    3003650116-2018-00001
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    May 18, 2018
    Report Date
    May 22, 2018
    Manufacturer
    MAGIC MOBILITY
    Product Code
    ITI
    PMA / PMN Number
    K030783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BACKRETS RECLINE MECHANISM FAILED. CLIENT RECLINED ABRUPTLY. CHAIR WAS SENT TO MAGIC MOBILITY ON (B)(6) TO REPAIR THE BACKREST. CLIENT WAS TAKEN INTO HOSPITAL WITH REPORTS OF BRUISING AND MINOR PAIN. THE CLIENT'S WIFE WAS CONTACTED ON (B)(6) AND CONFIRMED THIS, BUT WOULDN'T GIVE CONSENT FOR MAGIC TO SPEAK TO THE DOCTORS OR ACCESS THERAPIST REPORTS. MAGIC WILL CONTINUE TO ASK THE WIFE FOR OFFICIAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488237 MAGIC MOBILITY FRONTIER V6 ITI MAGIC MOBILITY FRONITER V6

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization