BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3133602 · Received May 29, 2013

    Report

    Report Number
    1525712-2013-04197
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    January 17, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE (01/17/2013). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL (05/22/2013). POTENTIAL FOR INJURY ASSOCIATED WITH A STROLLER HANDLE ON A SPRXT MANUAL WHEELCHAIR ALLEGEDLY BREAKING OFF. THIS COULD CAUSE INSTABILITY WITH THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    PROVIDER STATES UNIT'S STROLLER HANDLE IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237187 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SPRXTF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other