BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2955018 · Received February 11, 2013

    Report

    Report Number
    1525712-2013-00988
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 10, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE PRONTO M91 BRAKES WERE NOT HOLDING, AND THE UNIT WOULD ROLL AWAY, RESULTING IN THE USER SCRAPING HIS SIDE WHILE TRANSFERRING FROM A RECLINER TO THE UNIT. ADDITIONALLY, IT WAS REPORTED THAT HE HAS ALSO FELL ON (B)(6) 2013 ((B)(6) =MDR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58101 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M91

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other