BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITYVAC

    MDR report key: 662774 · Received November 29, 2005

    Report

    Report Number
    MW1037639
    Event Type
    Malfunction
    Date Received
    November 29, 2005
    Date of Event
    November 21, 2005
    Report Date
    November 29, 2005
    Manufacturer
    COOPER SURGICAL, INC.
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VACUUM EXTRACTION X2 FOR 36 5/7 WEEK GESTATIONAL AGE INFANT. AT 1910, VACUUM M-CUP USED, 90 SECONDS, NO POP-OFFS. POSITION OA- SEVERE VARIABLE DECELS BY EXTERNAL MONITOR-OXYTOCIN AUGMENTATION. APGARS 9 AND 9-1-ADMISSION OFC 13"-33CM-. THE NEXT DAY 0500. BABY MOTTLED, SL TEMP DECREASE, GENERAL SCALP EDEMA, BABY WINCES WITH HANDLING, OFC 35CM. 0600-MD ORDERS: TRANSFER BABY TO SEE LABS. OFC AND BPS DONE EVERY 1 HR. 0730 T&C REPEAT HGBS. 0940 BABY TRANSFUSED WITH 60ML PRBC. THREE DAYS LATER: CT NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC M-STYLE MUSHROOM CAP VACUUM ASSIST DELIVERY SYSTEM HDB COOPER SURGICAL, INC. 10047 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other