BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMEDA EGNELL VACUUM PUMP

    MDR report key: 192091 · Received October 16, 1998

    Report

    Report Number
    192091
    Event Type
    Death
    Date Received
    October 16, 1998
    Date of Event
    September 24, 1998
    Report Date
    October 15, 1998
    Manufacturer
    HOLLISTER, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING ORIGINAL 3500A USER FACILITY REC'D THE RESULTS OF THE AUTOPSY WHICH FOUND AS FOLLOWS: NO SIGNIFICANT MATERNAL MEDICAL HISTORY, NEONATAL DEATH OF FULLTERM MALE INFANT (7 DAYS), MASSIVE SUBDURAL AND INTRAPARENCHYMAL HEMORRHAGE, INVOLVING RIGHT FRONTOPARIETAL CEREBRAL CORTEX; STATUS POST FRONTAL CRANIOTOMY AND SURGICAL EVACUATION ON 25 SEPT 1998. ARTERIOVENOUS MALFORMATION, EXTENSIVE, INVOLVING RIGHT FRONTAL AND PARIETAL CEREBRAL CORTEX. MULTIFOCAL, SUBARACHNOID, INTRAPARENCHYMAL AND INTRAVENTRICULAR HEMORRHAGE, MARKED CEREBROVASCULAR CONGESTION, CEREBRAL EDEMA, MASSIVE NECROSIS AND OTHER FEATURES CONSISTENT WITH "RESPIRATOR BRAIN SYNDROME," SEQUELAE OF GLOBAL ANOXIA/HYPOXIA, CLINICAL HISTORY OF ANTEMORTEM INTRAVENTRICULAR HEMORRHAGE; UNCAL HERNIATION; RIGHT TO LEFT SUBFALCINE HERNIATION; NO OTHER EXTERNAL MACROSCOPIC CONGENITAL ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMEDA EGNELL VACUUM PUMP VACUUM ASSISTED DELIVERY HDB HOLLISTER, INC. 17 U *
    2 AMEDA EGNELL VACUUM PUMP VACUUM ASSISTED DELIVERY HDB HOLLISTER, INC. 17 U *
    3 AMEDA EGNELL VACUUM PUMP VACUUM ASSISTED DELIVERY HDB HOLLISTER, INC. 30 II *
    4 AMEDA EGNELL VACUUM PUMP VACUUM ASSISTED DELIVERY HDB HOLLISTER, INC. 30 II *
    5 AMEDA EGNELL VACUUM PUMP VACUUM ASSISTED DELIVERY HDB HOLLISTER, INC. 30 II *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Death