BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI COMPLETE VACUUM DELIVERY SYSTEM

    MDR report key: 7232966 · Received January 31, 2018

    Report

    Report Number
    1722684-2018-00001
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    January 9, 2018
    Report Date
    January 31, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    UDI-DI
    00814247020659
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CEPHALOHEMATOMAS ARE COLLECTIONS OF BLOOD THAT ACCUMULATE UNDER THE PERIOSTEUM OF THE SKULL BONES, USUALLY THE PARIETAL, AND ARE LIMITED TO THE CONFINES OF A CRANIAL BONE BECAUSE THE PERIOSTEUM IS CONTINUOUS WITH THE PERICRANIUM THROUGH THE SUTURE LINES. REPORTED INCIDENCES FOR CEPHALOHEMATOMAS RANGE IN VACUUM AND SPONTANEOUS DELIVERIES RANGE FROM 1 PERCENT TO 25 PERCENT WITH A MEAN INCIDENCE OF 6 PERCENT. THE WIDE VARIATION IN REPORTED INCIDENCE MAY BE PARTLY EXPLAINED BY THE FACT THAT CEPHALOHEMATOMAS MAY DEVELOP SEVERAL HOURS AND SOMETIMES DAYS AFTER THE BIRTH AND ALSO BECAUSE SMALL HEMATOMAS MAY PASS UNNOTICED OR THE DIAGNOSIS MAY BE INCORRECT. CEPHALOHEMATOMAS THAT OCCUR DURING A VACUUM DELIVERY HAVE BEEN ASSOCIATED WITH POOR CUP APPLICATION ON THE FETAL SCALP AND DIFFICULT DELIVERIES. RESOLUTION OF CEPHALOHEMATOMAS OCCURS RAPIDLY OVER A MATTER OF DAYS BUT LARGE CEPHALOHEMATOMAS MAY TAKE LONGER, POSSIBLY TWO OR THREE WEEKS TO DISAPPEAR COMPLETELY. COMPLICATIONS ARE RARE AND NO SPECIFIC THERAPY IS REQUIRED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION PROVIDED BY THE DISTRIBUTOR: "JUNIOR REG APPLIED CUP - POP OFF, IT WAS DISCARDED. DR (B)(6) APPLIED SECOND CUP (SAMPLE ENCLOSED) BABY MADE PROGRESS, SLOW LOSS OF SUCTION. BABY DELIVERED WITH CEPHALOHAEMATOMA, WENT TO NICU. BABY AND MUM ARE FINE. LOT OLM RECORDED 171117"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76372 KIWI COMPLETE VACUUM DELIVERY SYSTEM FETAL VACUUM EXTRACTOR HDB CLINICAL INNOVATIONS, LLC VAC-6000MTE 171117 00814247020659

    Patients

    Seq Age Sex Outcome Treatment
    1 1 HR Hospitalization