BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK

    MDR report key: 5057062 · Received September 4, 2015

    Report

    Report Number
    9616091-2015-02199
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Report Date
    August 11, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    CASTER FORKS HAVE BENT TO ONE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587360 SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK WHEELCHAIR, MECHANICAL IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other