BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CORD CLAMP

    MDR report key: 6993317 · Received November 1, 2017

    Report

    Report Number
    6993317
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    December 5, 2016
    Report Date
    December 8, 2017
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN FURTHER DETAILS SURROUNDING THE INCIDENT HAVE BEEN UNSUCCESSFUL. - ATTACHMENT: [MEDWATCH FROM CUSTOMER.PDF].

    Description of Event or Problem · 1

    CORD CLAMP APPLIED. UPON MOVING INFANT TO THE WARMER, CORD CLAMP BECAME RESTRICTED AGAINST ANOTHER OBJECT AND TORE UMBILICAL CORD, CAUSING BLEEDING TO INFANT AT UMBILICAL CORD SITE.

    Description of Event or Problem · 1

    PER FACILITY MEDWATCH: A CORD CLAMP WAS APPLIED TO AN INFANT. WHEN THE INFANT WAS MOVED TO THE WARMER, THE CORD CLAMP BECAME RESTRICTED AGAINST ANOTHER OBJECT AND TORE THE UMBILICAL CORD, CAUSING BLEEDING TO THE INFANT AT THE UMBILICAL CORD SITE. ATTEMPTS TO GET FURTHER DETAILS FROM THE USER FACILITY BY THE MANUFACTURER HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773316 UMBILICAL CORD CLAMP CLAMP, UMBILICAL HFW HOLLISTER INCORPORATED D 9411 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 0.0 DA