BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORCO FOLDING SHOWER BENCH

    MDR report key: 2194716 · Received July 20, 2011

    Report

    Report Number
    2939821-2011-00001
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    January 8, 2010
    Report Date
    July 14, 2011
    Manufacturer
    APEX MEDICAL CORP.
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED SHE FELL IN THE BATHTUB AND HAD PAIN IN HER HIP AND BACK. SHE MENTIONED THAT THE SCREWS RIPPED OUT OF THE BENCH SIDEWAYS CAUSING HER TO FALL. THE INCIDENT HAPPENED ON (B)(6) 2010. SHE WAS SCHEDULED FOR AN MRI THE FOLLOWING WEEK. SHE STATED SHE HAD PREVIOUS BROKEN LEGS, HIPS AND HAND PREVIOUS TO THIS INCIDENT AS WELL AS DIFFICULTY BREATHING AND HER DIFFICULTY BREATHING INCREASED SINCE THE INCIDENT. FROM THE VOICE MAIL REC'D ON (B)(6) 2010 FROM THE CUSTOMER, AFTER THE MRI, THE RESULTS SHOWED A CRUSHED VERTEBRAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORCO FOLDING SHOWER BENCH SHOWER BENCH INM APEX MEDICAL CORP. NC87102

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability