BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO CIRCUMCISION CLAMP

    MDR report key: 2503124 · Received March 20, 2012

    Report

    Report Number
    1924066-2012-00004
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS INC.
    Product Code
    HFX
    PMA / PMN Number
    PREAMENDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLAMP HAS NOT BEEN RETURNED FOR EVALUATION. DATE CODE ON THE CLAMP INDICATES IT WAS MADE IN 07/2008. THESE CLAMPS HAVE A ONE YEAR WARRANTY. MANUAL STATES THE FOLLOWING: "WARNING: THIS CLAMP MUST NEVER BE USED IF COMPONENT PARTS ARE DAMAGED, MISSING, CLEARLY WORN OR THE ASSEMBLED DEVICE DOES NOT PERFORM AS DESCRIBED. PRIOR TO INITIATING THE SURGICAL PROCEDURE YOU MUST INSURE THAT EXPECTED CLAMPING FUNCTION HAS BEEN PROPERLY ACHIEVED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BELL/STUD OF THE CIRCUMCISION CLAMP BROKE WHEN THE DOCTOR WAS TIGHTENING IT DOWN TO PERFORM A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOMCO CIRCUMCISION CLAMP CIRCUMCISION CLAMP HFX ALLIED HEALTHCARE PRODUCTS INC. 02-02-0501 0708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other