BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELMED INCORPORATED

    MDR report key: 21682370 · Received March 24, 2025

    Report

    Report Number
    1412854-2005-20252
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    November 30, 2024
    Report Date
    March 24, 2025
    Manufacturer
    ELMED INCORPORATED
    Product Code
    HFB
    UDI-DI
    00198506002632
    PMA / PMN Number
    D543830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELMED INCORPORATED GOMCO STYLE CIRCUMCISION CLAMP, NEWBORN 1.3 CM (1/2") HFB ELMED INCORPORATED ST315502 E0824 00198506002632

    Patients

    Seq Age Sex Outcome Treatment
    1