BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOALA EXTERNAL

    MDR report key: 18897684 · Received March 12, 2024

    Report

    Report Number
    MW5152782
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    March 9, 2024
    Report Date
    March 9, 2024
    Manufacturer
    MVF DISPOSABLES/CLINICAL INNOVATIONS, LLC
    Product Code
    HFN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UTERINE RUPTURE AFTER USING IUPC FOR AMNIOINFUSION. IUPC PLACED AT 0254. AMNIOINFUSION STARTED AT 0905 300 ML BOLUS AT RATE OF 999ML/HR THEN 50 ML/HR. WAS STARTED APPROXIMATELY 90 MINUTES PRIOR TO IDENTIFICATION OF UTERINE RUPTURE. NO FLUID RETURNED FROM AMNIOINFUSION, ABDOMEN PALPATED SOFT BETWEEN CONTRACTIONS. URGENT C/S DUE TO CONCERN FOR UTERINE RUPTURE, EXHIBITED CHANGE IN SVE AND LOSS OF ABILITY TO FIND FHT WITH EXTERNAL AND INTERNAL MONITORS. SURGEON NOTED PLACENTAL FRAGMENTS AND FETAL HEAD PALPABLE EXTRAUTERINE CONSISTENT WITH UTERINE RUPTURE. THERAPY DURATION: 1.5 HOUR. UTERINE ACTIVITY, MEASUREMENT OF MVUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132392 KOALA EXTERNAL TRANSDUCER, PRESSURE, INTRAUTERINE HFN MVF DISPOSABLES/CLINICAL INNOVATIONS, LLC 231411

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Life Threatening