BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVC SHOWER CHAIR W/BACK-1PK 9153644133

    MDR report key: 4864974 · Received June 24, 2015

    Report

    Report Number
    1125779-2015-00109
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Report Date
    June 8, 2015
    Manufacturer
    GARDEN CITY MEDICAL
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PATIENT WAS SITTING ON SHOWER CHAIR. REACHED UP FOR HAND HELD SHOWER HEAD AND BACK OF CHAIR SNAPPED. PATIENT WAS TAKEN TO URGENT CARE AND HAD BUMP ON LEFT SIDE OF HEAD AND PAIN TO LEFT SIDE OF HEAD AND PAINT TO LEFT SHOULDER. PATIENT STATES DOCTOR SAID HE WAS FINE AND XRAY SHOWED NO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410147 IVC SHOWER CHAIR W/BACK-1PK 9153644133 ADAPTOR, HYGIENE ITJ GARDEN CITY MEDICAL SELFCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 Hospitalization