BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI

    MDR report key: 18434402 · Received January 3, 2024

    Report

    Report Number
    18434402
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 7, 2023
    Report Date
    December 19, 2023
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A PHYSICIAN ATTEMPTED TO USE KIWI VACUUM TO ASSIST WITH PLANNED C-SECTION DELIVERY. THE DEVICE DID NOT HAVE SUCTION. THE PHYSICIAN USED TWO DIFFERENT KIWI¿S WITHOUT SUCCESS. 1. LOT# 220671. 2. LOT# 230346.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588667 KIWI EXTRACTOR, VACUUM, FETAL HDB LABORIE MEDICAL TECHNOLOGIES 220671, 230346

    Patients

    Seq Age Sex Outcome Treatment
    1 9490 DA Female