BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITYVAC

    MDR report key: 501708 · Received November 28, 2003

    Report

    Report Number
    MW1030425
    Event Type
    Malfunction
    Date Received
    November 28, 2003
    Date of Event
    September 20, 2003
    Report Date
    November 28, 2003
    Manufacturer
    PRISM HEALTH CARE
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VACUUM ASSISTED VERTEX VAGINAL DELIVERY OF PT. NOTED NEXT DAY TO HAVE SUBGALEAL HEMORRHAGE BECAUSE OF MILD ENCEPHALOPATHY AND DESATURATION SPELLS. CT SCAN WAS DONE WHICH SHOWED SMALL SUBDURAL HEMORRHAGE. PT WAS NPO LONGER AND REQUIRED A CT SCAN AND EXTRA LAB WORK AS A RESULT OF THIS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC VACUUM EXTRACTOR HDB PRISM HEALTH CARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY