BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3024285 · Received March 27, 2013

    Report

    Report Number
    1531186-2013-01312
    Date Received
    March 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    LERADO GLOBAL
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CONSUMER (B)(6)'S WIFE CALLED IN AND ALLEGES THAT THE LOCKING MECHANISM ON THE (B)(6) IS TO SHARP AND HAS A CUT TO HER HUSBAND'S' LEG WHICH CAUSE BLEEDING ON THREE SEPARATE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126992 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS LERADO GLOBAL 1302RTS

    Patients

    Seq Age Sex Outcome Treatment
    1 87 Other