BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 139626 · Received December 5, 1997

    Report

    Report Number
    1648571-1997-00009
    Event Type
    Malfunction
    Date Received
    December 5, 1997
    Date of Event
    November 14, 1997
    Report Date
    December 5, 1997
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SHORTLY AFTER THE INFANT WAS BORN THEY OBSERVED BLOOD LEAKAGE. UPON INSPECTION THE STAFF REPORTED THAT THE CLAMP OPENED UP. NO ADD'L MED TREATMENT WAS REQUIRED. ANOTHER CLAMP WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL CLAMP UMBILICAL CLAMP HFW QFC PLASTICS QFC-650 163-97

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention