BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAMP, CIRCUMCISION

    MDR report key: 3213417 · Received March 13, 2012

    Report

    Report Number
    3213417
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MOGEN CIRCUMCISION INSTRUMENTS
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION: A (B)(6) BABY UNDERWENT CIRCUMCISION USING A MOGEN CLAMP. PHYSICIAN DID NOT NOTE ANYTHING UNUSUAL DURING PROCEDURE: PLACED CLAMP AND PUSHED PENIS DOWN TO OBTAIN FORESKIN. THE PHYSICIAN BELIEVED SHE HAD OBTAINED FORESKIN AND REMOVED FORESKIN. IMMEDIATELY AFTER REMOVAL, BABY STARTED BLEEDING. PRESSURE APPLIED WITH SURGICEL. PATIENT TRANSFERRED TO NICU WHERE IT WAS NOTED THAT 1/3 OF THE GLANS HAD BEEN REMOVED AND URETHRA DAMAGED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: ROUTINE CIRCUMCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAMP, CIRCUMCISION HFX MOGEN CIRCUMCISION INSTRUMENTS 102

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Hospitalization| R