BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6833 UMBILICAL CORD CLAMP, 100/CS

    MDR report key: 280821 · Received May 31, 2000

    Report

    Report Number
    1046367-2000-00022
    Event Type
    Malfunction
    Date Received
    May 31, 2000
    Date of Event
    May 2, 2000
    Report Date
    May 31, 2000
    Manufacturer
    DEROYAL SURGICAL
    Product Code
    HFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED INCIDENT OF NEWBORN BLOOD LOSS FOLLOWING UMBILICAL CORD CLAMPING PROCEDURE. USER FACILITY REPORTED NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6833 UMBILICAL CORD CLAMP, 100/CS 7N8 UMBILICAL CORD CLAMP HFW DEROYAL SURGICAL 07 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other