BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION CIRCLAMP

    MDR report key: 1321221 · Received February 19, 2009

    Report

    Report Number
    1824619-2009-00002
    Event Type
    Injury
    Date Received
    February 19, 2009
    Report Date
    February 4, 2009
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    HFX
    PMA / PMN Number
    K890897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A DAY AFTER THE CIRCUMCISION PROCEDURE, THE SKIN ROLLED DOWN THE SHAFT OF THE PENIS AND THE SURGEON HAD TO SUTURE THE AREA. TRI-STATE'S SALES REPRESENTATIVE DISCUSSED THE CIRCLAMP PROCEDURE WITH THE PHYSICIAN INCLUDING THE NEED FOR THE CLAMP TO STAY ON FOR FIVE MINUTES IN ORDER TO ACHIEVE HEMOSTASIS. THE CUSTOMER WAS UNABLE TO CONFIRM THE LOT NUMBER RELATED TO THE ADVERSE EVENT. LOT# 2008112401 AND LOT# 2008091501 WERE THE CURRENT LOT NUMBERS AVAILABLE IN THEIR INVENTORY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION CIRCLAMP HFX, CLAMP, CIRCUMCISION HFX TRI-STATE HOSPITAL SUPPLY CORP. 310CR 2008112401

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Required Intervention