BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOGEN CIRCUMCISION CLAMP

    MDR report key: 288026 · Received July 28, 2000

    Report

    Report Number
    6000008-2000-00004
    Event Type
    Injury
    Date Received
    July 28, 2000
    Report Date
    July 28, 2000
    Manufacturer
    E.G. MEDICON
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SOME DOCTORS ALLEGE ITEM IS CUTTING BADLY. THEY FURTHER ALLEGE THAT WHEN THE CLAMP IS PLACED ON THE INFANT, IT APPLIES EXCESSIVE FORCE WHICH RESULTS IN PREMATURE CUTTING OF THE SKIN. IN SOME CASES, SILVER NITRATE STICKS AND GEL FOAM WERE REQUIRED TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOGEN CIRCUMCISION CLAMP INSTRUMENT HFX E.G. MEDICON GL7021 XMIT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention