BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITYVAC

    MDR report key: 184643 · Received August 26, 1998

    Report

    Report Number
    184643
    Event Type
    Injury
    Date Received
    August 26, 1998
    Date of Event
    February 19, 1998
    Report Date
    August 20, 1998
    Manufacturer
    PRIS TECH., INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BABY TRANSFERRED 12 HOURS AFTER DELIVERY FOR NEUROLOGICAL EVALUATION. BABY'S MOTHER WAS 30 YRS OLD, BORN 5/24/1967, AND WEIGHED 157 LBS. * USER FACILITY FIRST BECAME AWARE OF EVENT IN 7/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC OBSTETRICAL VACUUM KIT HDB PRIS TECH., INC. 007 M CUP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization| L| R