BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOGEN CLAMP

    MDR report key: 12007887 · Received June 16, 2021

    Report

    Report Number
    12007887
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    March 29, 2020
    Report Date
    June 9, 2021
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRIOR TO PERFORMING CIRCUMCISION ON PATIENT, NEONATAL NURSE PRACTITIONER (NNP) TESTED MOGEN CLAMP BY OPENING, CLOSING, AND LOCKING CLAMP WITHOUT ANY ISSUES. DURING CIRCUMCISION, NNP WAS ABLE TO FULLY CLOSE THE MOGEN ON THE PATIENT'S FORESKIN BUT WAS UNABLE TO LOCK CLAMP INTO PLACE. WHEN NNP OPENED THE MOGEN, THE FORESKIN WAS SEVERED SO SHE WAS ABLE TO RECLOSE THE MOGEN AND REMOVE THE FORESKIN WITHOUT ANY COMPLICATIONS. MOGEN WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909937 MOGEN CLAMP CLAMP, CIRCUMCISION HFX

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA