BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAIL BED

    MDR report key: 1141623 · Received August 29, 2008

    Report

    Report Number
    MW5008110
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 29, 2008
    Product Code
    FMS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS THAT SON WAS IN THE HOSPITAL FOR 2 WEEKS AND WAS PLACED IN A VAIL BED, IN 2008 TWO DAYS AFTER ADMISSION, HER SON LOST HIS BALANCE WHILE IN THE VAIL BED AND HIT HIS TOOTH ON THE RAIL, RESULTING IN THE LOSS OF HIS RIGHT FRONT TOOTH AND LOOSING OF OTHER TEETH. REPORTER STATES THAT HER SON'S SITTER LEFT THE ROOM AND WHEN SHE RETURNED, SHE FOUND THE PT IN A POOL OF BLOOD AND BLOOD WAS SPLATTERED ON THE FLOOR AROUND THE BED. PT WAS TAKEN TO THE DENTIST BY AMBULANCE, AND THE DENTIST INFORMED THE MOTHER THAT THE TOOTH COULD NOT BE REPLACED. AFTER THIS INCIDENCE, THE REPORTER STATES THAT SHE CALLED STRYKER TO INFORM THEM WHAT HAPPENED AND WAS TOLD THAT THEY DID NOT MAKE VAIL BEDS AND THAT THE FDA HAD TAKEN THE BED OFF THE MARKET ABOUT FIVE YEARS BY THE FDA DUE TO SAFETY ISSUES. REPORTER TOLD STRYKER THAT THEIR NAME WAS ON THE BED, AND THIS WAS THE REASON SHE CALLED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAIL BED NONE FMS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R