BEUDAMED
    FDA Adverse Event Summary report: N

    KIWI WITH PALM PUMP

    MDR report key: 4254340 · Received October 29, 2014

    Report

    Report Number
    4254340
    Date Received
    October 29, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 29, 2014
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    OBSTETRICIAN USED THE KIWI VACUUM FOR A VACUUM EXTRACTION USING PROPER PROCEDURE. THE FOLLOWING DAY THE AFFECTED AREA OF THE INFANT'S SCALP WAS COVERED WITH LARGE RAISED BLISTERS IN A DEFINED CIRCULAR PATTERN.WHEN I SPOKE TO THE NURSE SHE SAID THAT THE DOC DID EVERYTHING CORRECT. WHILE I WAS TALKING TO HER, THERE WERE OTHER OB NURSES AROUND AND THEY ALL SAID THEY DID NOT LIKE THE KIWI BECAUSE THE CUP WAS SO HARD. THE FACILITY NOTIFIED THE MANUFACTURER, WHO INDICATED THAT THE EVENT IS CONSISTENT WITH SENSITIVE INFANT SKIN, ALTHOUGH RARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691446 KIWI WITH PALM PUMP EXTRACTOR, VACUUM, FETAL HDB CLINICAL INNOVATIONS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY NO OTHER THERAPIES