BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCUMCISION CLAMP

    MDR report key: 900831 · Received August 14, 2007

    Report

    Report Number
    900831
    Event Type
    Malfunction
    Date Received
    August 14, 2007
    Date of Event
    August 8, 2007
    Report Date
    August 14, 2007
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A 1.6 GOMCO CLAMP DID NOT SECURE TIGHTLY BUT IT WAS NOT APPARENT UNTIL THE CLAMP WAS FURTHER EVALUATED AFTER THE PROCEDURE. ARTERIAL BLEEDING RESULTED FROM EQUIPMENT FAILURE. A 5-0 VICRYL WAS PLACED AROUND EACH VESSEL BY THE ATTENDING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUMCISION CLAMP CIRCUMCISION CLAMP HFX ALLIED HEALTH CARE PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA NO OTHER THERAPIES