BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEM

    MDR report key: 20915715 · Received December 11, 2024

    Report

    Report Number
    MW5163566
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    December 7, 2024
    Report Date
    December 10, 2024
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FINDINGS VIABLE FEMALE INFANT, MATERNAL ABDOMINAL WALL/RECTUS WITH MORE THAN USUAL TISSUE TENSION REQUIRING VACUUM ASSISTANCE, FIRST PLACEMENT IMMEDIATELY POPPED OFF-ASSUME DEVICE DYSFUNCTION, 2 SUBSEQUENT POP OFFS OCCURRED WITH LESS THAN USUAL TRACTION, AND FETAL HEAD DELIVERED WITH FINAL APPLICATION PLUS SMALL INCISION OF LEFT RECTUS ALLOWING FETAL HEAD TO EASILY DELIVER AGAIN WITH LESS THAN USUAL TRACTION OF THE KIWI DEVICE, BIRTH WEIGHT 2368G, PLACENTA INTACT WITH APPROXIMATELY 30% AREA CONSISTENT WITH ABRUPTION. BRUISE NOTED ON NEWBORN HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377021 KIWI COMPLETE VACUUM DELIVERY SYSTEM EXTRACTOR, VACUUM, FETAL HDB LABORIE MEDICAL TECHNOLOGIES CORP. 241305

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female