BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION CIRCLAMP

    MDR report key: 875155 · Received July 3, 2007

    Report

    Report Number
    1824619-2007-00001
    Event Type
    Injury
    Date Received
    July 3, 2007
    Date of Event
    May 7, 2007
    Report Date
    July 3, 2007
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    HFX
    PMA / PMN Number
    K890897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHONE CALL WAS PLACED TO THE RISK MANAGER IN 2007. DURING THE CONVERSATION ,SHE STATED THAT THE PHYSICIAN DID NOT THINK THE DEVICE WAS DEFECTIVE, BUT THE WASHER PREVENTED PROPER TIGHTENING. INFORMED RISK MANAGER THAT IMPROPER ASSEMBLY CAN PREVENT FULL TIGHTENING OF THE CLAMP. SHE STATED THIS INFO WOULD BE COMMUNICATED TO TE PHYSICIAN. TRI-STATE'S SALES REPRESENTATIVE WILL REVIEW THE PROPER ASSEMBLY INSTRUCTIONS WITH THE ACCOUNT. NOTE: IF THE WASHER IS PLACED UNDER THE CLAMP ARM INSTEAD OF ABOVE THE ARM, IT WILL PREVENT ADEQUATE TIGHTENING OF THE CLAMP.

    Description of Event or Problem · 1

    CIRCUMCISION PERFORMED ON NEWBORN. DEVICE DID NOT CLAMP CLOSED PROPERLY. PROCEDURE COMPLICATED BY POOR HEMOSTASIS REQUIRING SURGICAL APPLICATION. HALF THE SKIN ON ANTERIOR SHAFT OF PENIS DENUDED AND APPROXIMATELY 2 MM OF DENUDED SHAFT POSTERIORLY. EXPECTED TO HEAL APPROPRIATELY WITHOUT FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION CIRCLAMP CIRCUMCISION CLAMP HFX TRI-STATE HOSPITAL SUPPLY CORP. CR330

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention