BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOGEN CIRCUMCISION CLAMP

    MDR report key: 1040929 · Received May 9, 2008

    Report

    Report Number
    1423507-2008-00043
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 8, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE LOT NUMBER, THE DEVICE HISTORY COULD NOT BE REVIEWED AND THE CAUSE OF THE FAILURE COULD NOT BE DETERMINED. IF MORE INFO IS LEARNED. A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THERE WAS A FAIR AMOUNT OF BLEEDING AFTER A CIRCUMCISION. ADDITIONALLY, THE PHYSICIAN STATED NO PERMANENT DAMAGE WAS DONE, THE BLEEDING WAS PROMPTLY NOTED AND SUTURING REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOGEN CIRCUMCISION CLAMP CLAMP HFX CARDINAL HEALTH GL7021 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BABY Required Intervention