BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4813307 · Received June 2, 2015

    Report

    Report Number
    9616091-2015-01415
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 6, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE BEARING CAP ON THE REAR WHEEL HAS CAME OUT. THE DEALER STATES THAT THE DEVICE IS FINE WITH NO PHYSICAL DAMAGE. THE DEALER ALSO STATES THAT THE WHEEL LOCK HAS BECOME BENT AND IS NO LONGER TOUCHING THE WHEEL. THE DEALER HAS NO FURTHER INFORMATION TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355451 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