BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECUREALL ONE PIECE BODY HOLDER

    MDR report key: 231863 · Received July 14, 1999

    Report

    Report Number
    9616096-1999-00004
    Event Type
    Death
    Date Received
    July 14, 1999
    Date of Event
    May 10, 1999
    Report Date
    June 9, 1999
    Manufacturer
    TECNOL, INC.
    Product Code
    FMQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 05/10/1999 PT FOUND IN HOSPITAL ROOM ON FLOOR KNEELING WITH ARMS CROSSED ON SIDE OF BED. POSEY VEST ON PT AS SHE WAS FOUND ON OPPOSITE SIDE OF SIDERAILS (4 UP) WITH RESTRAINT REMAINING TIED TO BED. PT UNRESPONSIVE, NO RESPIRATIONS OR HEART BEAT. PT WAS CODED AND TRANSFERRED TO SCU ON VENTILATOR. ON 05/11/1999 PT WAS EXTUBATED AND EXPIRED. UNK CAUSE OF DEATH WHETHER ATTRIBUTED TO POSEY VEST. WAS NOT ACCEPTED AS MEDICAL EXAMINER CASE NOR AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUREALL ONE PIECE BODY HOLDER PROTECTIVE RESTRAINT FMQ TECNOL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death