BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONTO M61

    MDR report key: 4820715 · Received June 5, 2015

    Report

    Report Number
    1525712-2015-03305
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PROVIDER STATES THE CHAIR WILL VEER TO THE LEFT A LITTLE BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365264 PRONTO M61 WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET M91

    Patients

    Seq Age Sex Outcome Treatment
    1 Other