BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOGEN CLAMP CIRCUMCISION CLAMP

    MDR report key: 10179996 · Received June 19, 2020

    Report

    Report Number
    MW5095141
    Event Type
    Injury
    Date Received
    June 19, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 1, 2020
    Manufacturer
    ELMED INC.
    Product Code
    HFX
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED CIRCUMCISION USING MOGEN CLAMP. WHEN HE RELEASED THE CLAMP, HE HAD AMPUTATED THE HEAD OF GLANS PENIS WITH URETHRA. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637838 MOGEN CLAMP CIRCUMCISION CLAMP CLAMP, CIRCUMCISION HFX ELMED INC. E0220

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Hospitalization