BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYSTIC 2 MITYVAC SOFT BELL CUP VACUUM ASSIST DELIVERY

    MDR report key: 1177603 · Received September 25, 2008

    Report

    Report Number
    MW5008413
    Event Type
    Death
    Date Received
    September 25, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 25, 2008
    Manufacturer
    COOPER SURGICAL INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BABY WAS BORN VAGINALLY USING MYSTIC 2 MITYVAC SOFT BELL CUP VACUUM. NO SIGNS OF PROBLEMS WITH THE DEVICE, BUT PT WAS TRANSFERRED TO TERTIARY CARE HOSPITAL AFTER SERIOUS SYSTEM FAILURES. AT THIS WRITING, IT IS UNCLEAR WHAT THE CAUSE OF THE BABY'S DEATH WAS ATTRIBUTED TO. HOWEVER, IT IS IN THE LITERATURE TO REPORT ANY ADVERSE EVENTS RELATED TO THIS TYPE OF PRODUCT. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: DELIVERY EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYSTIC 2 MITYVAC SOFT BELL CUP VACUUM ASSIST DELIVERY MITYVAC HDB COOPER SURGICAL INC. MYSTIC2 10058

    Patients

    Seq Age Sex Outcome Treatment
    1 Death