BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI OMNICUP

    MDR report key: 12924766 · Received December 2, 2021

    Report

    Report Number
    MW5105754
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 30, 2021
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    KIWI HARD CUP VACUUM DIFFICULT TO RELEASE. PROVIDER ATTEMPTED TO RELEASE X3, NNP BROKE SUCTION AND REMOVED VACUUM FROM INFANTS HEAD POST DELIVERY. INFANT APGARS 8/9, SUPERFICIAL BRUISING TO INFANT HEAD. (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817417 KIWI OMNICUP EXTRACTOR, VACUUM, FETAL HDB CLINICAL INNOVATIONS, LLC 214222

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female