BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION CIRCUMCISION TRAY NEWBORN NURSERY CIT6610AS

    MDR report key: 12032088 · Received June 17, 2021

    Report

    Report Number
    MW5101966
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 11, 2021
    Report Date
    June 15, 2021
    Manufacturer
    CENTURION MEDICAL PRODUCTS CORP.
    Product Code
    OHG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HEMOSTAT THAT CAME IN THE CENTURION CIRCUMCISION TRAY NEWBORN NURSERY KIT MALFUNCTIONED DURING PT'S CIRCUMCISION. THE HEMOSTAT BECAME STUCK WHILE IT WAS CLAMPED ON THE FORESKIN DURING CIRCUMCISION. PROVIDER UNABLE TO UNCLAMP HEMOSTAT REQUIRING TO CUT FORESKIN AROUND HEMOSTAT TO REMOVE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911172 CENTURION CIRCUMCISION TRAY NEWBORN NURSERY CIT6610AS CIRCUMCISION TRAY OHG CENTURION MEDICAL PRODUCTS CORP. CIT6610AS

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA