BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 19792514 · Received July 22, 2024

    Report

    Report Number
    19792514
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    March 3, 2024
    Report Date
    May 1, 2024
    Manufacturer
    ALLIED MEDICAL, LLC
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING NEONATAL CIRCUMCISION PROCEDURE, PROVIDER NOTED THAT THERE WAS EXCESSIVE BLEEDING AT THE SIDE AND NOTED GOMCO WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165335 GOMCO CLAMP, CIRCUMCISION HFX ALLIED MEDICAL, LLC 02--01-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Male