BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2940312 · Received February 2, 2013

    Report

    Report Number
    9616091-2013-00151
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO MDR REPORTS WILL BE SUBMITTED FOR THIS COMPLAINT, BECAUSE OF DIFFERENT EVENT DATES WERE REPORTED, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4) (MDR).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE CONSUMER THAT THE 9SL MECHANICAL WHEELCHAIR TIRES WERE WORN, AND ALLEGEDLY CAUSED HIM TO FALL OFF THE UNIT TWICE. THE PATIENT HAS A MEDICAL CONDITION WHICH HAS CAUSED THE LOSS OF LOWER EXTREMITY FUNCTIONS. ADDITIONALLY, IT WAS REPORTED THAT ON EACH OCCASION WHEN HE HAD FALLEN, EMERGENCY RESCUE WAS CALLED FOR ASSISTANCE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND SHOULD WE RECEIVE IT, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45429 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Other