BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMBILICAL CORD CLAMP

    MDR report key: 3812672 · Received May 1, 2014

    Report

    Report Number
    3007966929-2014-00015
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    HFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY AND THE DEVICE WAS USED ON A PT. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. CONVATEC WILL CONTINUE TO OBSERVE FOR TRENDS REGARDING THESE COMPLAINT TYPES. THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM MAY 1, 2011- SEPTEMBER 30, 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    PRODUCT DOES NOT GRIP TIGHTLY ENOUGH AND DOES NOT STOP THE BLOOD FLOW. THIS HAS CAUSED A BABY TO NEED BLOOD TRANSFUSION IN INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262239 UMBILICAL CORD CLAMP OPERATION ACCESSORIES HFW UNOMEDICAL LTD. 460-00 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention