BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4027340 · Received August 21, 2014

    Report

    Report Number
    1531186-2014-03412
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 24, 2014
    Manufacturer
    JUMAO - JM - E. CHINA
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ENDUSER'S HUSBAND ADVISED THAT THE RETAINING CLIP FROM FRONT RIGGINGS IS MISSING, NO INJURY. ENDUSER'S HUSBAND COULD NOT PROVIDE ANY FURTHER INFORMATION...(B)(4) UPDATE: (B)(4) CALLED IN WITH REF# STATING THAT IT WAS FOR RIGHT LEG. DEALER STATES RIGHT LEG REST IS FALLING OFF, CLIP HOLDS RIGGING ON IS MISSING. AFTER SPEAKING WITH TECH (B)(6) IT WAS DETERMINED THAT THE SNAP RING WAS MISSING. CUSTOMER NOT SURE ABOUT OTHER SIDE OF LEG REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505901 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 ITI JUMAO - JM - E. CHINA V18RLR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other