BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELMED INCORPORATED

    MDR report key: 21062533 · Received January 2, 2025

    Report

    Report Number
    1412854-2024-12241
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 30, 2024
    Report Date
    December 23, 2024
    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

    Narratives

    Additional Manufacturer Narrative · 0

    HAVE REQUESTED THE USER TO SEND BACK THE DEVICE FOR EVALUATION. HAVE RECEIVED PRODUCT BACK AND IT IS UNDERGOING REVIEW AND INSPECTION FOR INTENDED FUNCTIONALITY.

    Description of Event or Problem · 0

    ITEM: ST315502. GOMCO STYLE CIRCUMCISION CLAMP, NEWBORN 1.3 CM (1/2"). PER THE CUSTOMER, WHEN THE BELL WAS SEATED, IT WAS LOOSE. THIS CREATED AN INCOMPLETE HEMOSTASIS, RESULTING IN BLEEDING AFTER CIRCUMCISION. NO ADDITIONAL INJURY WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431573 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 NA Prefer Not To Disclose Other