BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOMCO CLAMP 1.3 CM

    MDR report key: 78797 · Received February 4, 1997

    Report

    Report Number
    78797
    Event Type
    Injury
    Date Received
    February 4, 1997
    Date of Event
    November 24, 1996
    Report Date
    December 6, 1996
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT USED FOR CIRCUMCISION DID NOT FULLY CLOSE WHICH RESULTED IN TISSUE MOVEMENT WHEN CUTTING FORESKIN--NECESSITATING SUTURING OF PENIS, SECONDARY TO BLEEDING. NEVER USED BEFORE--JUST OUT OF PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOMCO CLAMP 1.3 CM CIRCUMCISION CLAMP HFX ALLIED HEALTH CARE PRODUCTS, INC. UNK (SIZE=1.3 CM) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention