BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITYVAC

    MDR report key: 175842 · Received July 8, 1998

    Report

    Report Number
    175842
    Event Type
    Malfunction
    Date Received
    July 8, 1998
    Date of Event
    April 19, 1998
    Report Date
    June 26, 1998
    Manufacturer
    PRISTECH, INC.
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MADE AWARE OF EVENT OF 6/24/1998. MEDICAL RECORD REVIEWED 6/26/1998. INFANT WAS BORN ON 4/19/1998 AT 40 WEEKS GESTATION. "INTRAPARTUM COMPLICATIONS INCLUDED FAILURE TO PROGRESS, FETAL DISTRESS AND FETAL BRADYCARDIA .... DELIVERY WAS VIA VACUUM EXTRACTION UNDER NO ANESTHESIA." UPON PHYSICAL EXAMINATION OCCIPITAL CEPHALOHEMATOMA NOTED. INFANT DISCHARGED IN STABLE CONDITION ON 4/21/1998. INFANT ADMITTED AGAIN ON 4/24/1998 TO RULE OUT SEPSIS. REQUIRING TYLENOL FOR PAIN DUE TO LARGE CEPHALOHEMATOMA, RESOLVING. DISCHARGED TO HOME ON 4/26/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC DISPOSABLE VACUUM EXTRACTOR HDB PRISTECH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other MITYVAC II, MD 6130 (SUCTION DEVICE)