BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5264175 · Received December 3, 2015

    Report

    Report Number
    1525712-2015-05611
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Report Date
    November 10, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POSITION OF THE FOOTREST, CAMBER TUBE, BACK ANGLE, THE TAUTNESS OF THE BACK UPHOLSTERY AS WELL AS THE USER'S CONDITION ARE DIRECTLY RELATED TO THE WHEELCHAIR'S STABILITY. PAGE 21; PART NO 1110545; REV. F - 10/10 SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    DEALER STATED WHEELS ARE WORN OUT. PER TECH SERVICE, ONE SIDE IS FROZEN INTO THE CAMBER TUBE. THE OTHER SIDE THE BUTTON AND PLUNGER IS MISSING. NO CONSUMER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793403 SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET TA4

    Patients

    Seq Age Sex Outcome Treatment
    1