BEUDAMED
    FDA Adverse Event Summary report: N

    TOTGUARD

    MDR report key: 3209243 · Received June 28, 2013

    Report

    Report Number
    MW5030763
    Date Received
    June 28, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    GUARD RFID SOLUTIONS INC.
    Product Code
    HFW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TOTGUARD UMBILICAL TAG IN PLACE WITH DIVERGENT CORD CLAMP. INFANT'S UMBILICAL CORD DETACHED PREMATURELY FROM UMBILICUS DUE TO THE WEIGHT OF THE DIVERGENT CORD CLAMP AND TOTGUARD TAG. SCANT BLEEDING NOTED AT CORD SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296211 TOTGUARD INFANT SECURITY UMBILICAL TAG HFW GUARD RFID SOLUTIONS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA