BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIG BOYZ

    MDR report key: 1349426 · Received December 29, 2006

    Report

    Report Number
    1349426
    Event Type
    Injury
    Date Received
    December 29, 2006
    Date of Event
    November 30, 2006
    Report Date
    December 7, 2006
    Manufacturer
    BIG BOYZ INDUSTRIES INC.
    Product Code
    FNL
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS LYING ON SIDE IN BED. THE EXTENSION ON THE MATTRESS WAS VELCRO FASTENEAL IN PLACE. THE VELCRO WAS PEELING AWAY FROM THE MATTRESS CAUSING A GAP. THE EXTENSION PIECE OF THE MATTRESS ROLLED AND THE PATIENT FELL OUT OF BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIG BOYZ BIG BOY BED FNL BIG BOYZ INDUSTRIES INC. LOW BED 800

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization