BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAGNUM II

    MDR report key: 352340 · Received September 19, 2001

    Report

    Report Number
    1919278-2001-00003
    Event Type
    Death
    Date Received
    September 19, 2001
    Date of Event
    August 9, 2001
    Report Date
    September 19, 2001
    Manufacturer
    BURKE, INC.
    Product Code
    FNL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DIED OF CARDIAC ARREST WHILE LAYING ON BED. HOSPITAL STATED BED HAD NO CONNECTION WITH DEATH OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42618 MAGNUM II OBESE TREATMENT SYSTEM FNL BURKE, INC. MAGNUM II *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| O