BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION CIRCLAMP

    MDR report key: 18290964 · Received December 7, 2023

    Report

    Report Number
    MW5149006
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 30, 2023
    Report Date
    December 5, 2023
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CENTURIONCIRCLAMP WITH 1.3CM BELL REPROCESSED. REORDER 330CRK. LOT 2023092501. EXP 2028-06-30. THE BELL WAS CHECKED. WHEN THE PROVIDER PLACED THE BASE ON THE BABY AND TIGHTENED IT DOWN, SHE NOTICED THE BASE WAS "FLAKING" AND A SILVER PIECE WAS HANGING OFF THE BASE OF THE GOMCO. THE BELL WAS FINE AND NOTHING NOTED ON IT. WHEN SHE REMOVED THE BASE, SMALL SILVER FLECKS WERE NOTED. NO FLAKES EMBEDDED IN SKIN. NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75559 CENTURION CIRCLAMP CLAMP, CIRCUMCISION HFX 2023092501

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Other