BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACME

    MDR report key: 5124650 · Received July 10, 2004

    Report

    Report Number
    5124650
    Event Type
    Injury
    Date Received
    July 10, 2004
    Date of Event
    June 29, 2004
    Report Date
    July 12, 2004
    Manufacturer
    ACME (OUT OF BUSINESS)
    Product Code
    FMQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERSON WITH DEVELOPMENTAL DISABILITY WAS ABLE TO SHIFT HERSELF IN A FASHION TO GET A CHEST HARNESS AROUND HER NECK AND BE STRANGLED. WAS FOUND AND REVIVED BUT DEATH IS MOST LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACME CHEST HARNESS FMQ ACME (OUT OF BUSINESS)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| S