BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.1 GOMCO CLAMP

    MDR report key: 147008 · Received December 31, 1997

    Report

    Report Number
    147008
    Event Type
    Injury
    Date Received
    December 31, 1997
    Date of Event
    July 22, 1997
    Report Date
    August 21, 1997
    Manufacturer
    PROGRESSIVE MEDICAL INSTRUMENTATION INC.
    Product Code
    HFX
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BABY BOY CIRCUMCISED USING 1.1 GOMCO THAT WAS DEFECTIVE CAUSING INFANT TO BLEED A MODERATE AMOUNT. A 1.1 PLASTI BELL WAS APPLIED AND THE CIRCUMCISION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.1 GOMCO CLAMP CIRCUMCISION CLAMP HFX PROGRESSIVE MEDICAL INSTRUMENTATION INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention