BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIWI VACUME

    MDR report key: 304919 · Received November 14, 2000

    Report

    Report Number
    MW1020401
    Event Type
    Injury
    Date Received
    November 14, 2000
    Date of Event
    November 11, 2000
    Report Date
    November 14, 2000
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/22/00: NO FAILURE ANALYSIS WAS POSSIBLE ON THE DEVICE SINCE IT WAS NOT RETURNED. IT APPEARS THAT THE DEVICE FUNCTIONED PROPERLY. THE ABRASION WAS REPORTEDLY "SUPERFICIAL" AND REQUIRED NO SUTURING TO REPAIR. IN MFR'S OPINION, THE REPORTED NINE TRACTION PULLS APPEAR TO BE EXCESSIVE USE OF THE DEVICE.

    Description of Event or Problem · 1

    KIWI SILASTIC APPLIED WITH MOTHER'S CONSENT; AFTER NINE PULLS WITH KIWI WITH MOTHER PUSHING, CHILD DELIVERED. 5.5CM LACERATION NOTED ON BABY'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIWI VACUME SILASTIC DELIVERY DEVICE HDB CLINICAL INNOVATIONS, INC. VAC-6000M 000212

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention