BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI PRO

    MDR report key: 14160999 · Received April 19, 2022

    Report

    Report Number
    MW5109167
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Report Date
    April 15, 2022
    Manufacturer
    CLINICAL INNOVATIONS LLC.
    Product Code
    HDB
    UDI-DI
    00814247020666
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD USED KIWI TO ASSIST WITH A CESAREAN OF AN IUFD. WHEN SHE ATTEMPTED TO USE THE PALM PUMP FOR THE VACUUM, THERE WAS NO SUCTION PRODUCED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625859 KIWI PRO EXTRACTOR, VACUUM, FETAL HDB CLINICAL INNOVATIONS LLC. VAC-6000S 214692 00814247020666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown