BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONTO M61

    MDR report key: 4898355 · Received July 8, 2015

    Report

    Report Number
    1525712-2015-03759
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 11, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE END USER STATES THAT THE REAR WHEELS ARE WOBBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442531 PRONTO M61 WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET M91

    Patients

    Seq Age Sex Outcome Treatment
    1 Other