BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUMCISION CLAMP, 1.1 CM.

    MDR report key: 24306 · Received August 11, 1995

    Report

    Report Number
    MW1006689
    Event Type
    Injury
    Date Received
    August 11, 1995
    Date of Event
    July 1, 1995
    Report Date
    July 28, 1995
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    HFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CIRCUMCISION CLAMP PLACED IN USUAL FASHION. AFTER ADJUSTMENT OF INITIAL POSITIONING, FORESKIN REMOVAL WAS INITIATED. PROCEDURE HALTED IMMEDIATELY WHEN CLAMP WAS FELT TO SLIP DURING PROCEDURE. LACERATION INTO THE GLANS OF THE PENIS OCCURRED. CLAMP WAS REMOVED & THE PROCEDURE WAS ABORTED. PT REQUIRED SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUMCISION CLAMP, 1.1 CM. CLAMP HFX ALLIED HEALTH CARE PRODUCTS, INC. 500S BASE PLATE-SE1, ARM SE2

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Hospitalization| O