BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500 VS

    MDR report key: 2904413 · Received December 6, 2012

    Report

    Report Number
    1221084-2012-00022
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 6, 2012
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    PMA / PMN Number
    K960951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEELCHAIR USER REPORTED THAT THE BOLT WHICH IS ATTACHED THE ARMREST LINK TO THE ARMBAR OF THE CHAIR BROKE. USER REPORTED THAT HE FELL FORWARD AND HIT HIS JAW ON THE TABLE. WHILE THE USER REPORTED THAT HE DISLOCATED HIS JAW, HE NEVER SOUGHT MEDICAL ATTENTION. WHEELCHAIR USER INAPPROPRIATELY USES THE ARMRESTS TO TRANSFER TO AND FROM THE WHEELCHAIR, WHICH IS THE LIKELY CAUSE OF THE BOLT BREAKING. MANUFACTURER PREVIOUSLY ADVISED USER TO OBTAIN TRANSFER HANDLES BUT USER DECLINED. MANUFACTURER HAS REPAIRED THE WHEELCHAIR AND THE USER IS SATISFIED. MANUFACTURER ALSO HAS SUBMITTED A REPORT TO THE PRODUCT QUALITY AND DESIGN DEPARTMENT FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMOBIL C500 VS POWER WHEELCHAIR ITI PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1