BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURE ALL ONE PIECE BODY HOLDER

    MDR report key: 122911 · Received September 26, 1997

    Report

    Report Number
    8030643-1997-00008
    Event Type
    Death
    Date Received
    September 26, 1997
    Report Date
    August 27, 1997
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Product Code
    FMQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH RESTRAINT APPLIED WAS FOUND HANGING OVER SIDE OF BED. CORONER REPORTED CAUSE OF DEATH TO BE CORONARY FAILURE. ALL HOSP STANDARDS HAD BEEN FOLLOWED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death