BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMBILICAL CORD CLAMP

    MDR report key: 8008632 · Received October 26, 2018

    Report

    Report Number
    8008632
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    September 26, 2018
    Report Date
    November 28, 2018
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT REVEALED NO SIMILAR REPORTED INCIDENTS.

    Description of Event or Problem · 0

    THE UNIT WAS APPLIED BY THE PEDIATRICIAN IN THE OPERATING ROOM AFTER BIRTH. APPROXIMATELY 16 HOURS LATER, THE UNIT CAME OFF THE BABY. THE FATHER CAUGHT IT AND BLEEDING WAS MINIMAL. PRESSURE WAS APPLIED AND THE CORD WAS TIED OFF WITH UMBILICAL TAPE.

    Description of Event or Problem · 1

    UMBILICAL CORD CLAMP CAME OFF A BABY. FATHER CAUGHT IT AND BLEEDING WAS MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851267 UMBILICAL CORD CLAMP UMBILICAL CORD CLAMP HFW HOLLISTER INCORPORATED 9423 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention