BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION CIRCUMCISION TRAY

    MDR report key: 12016594 · Received June 16, 2021

    Report

    Report Number
    MW5101941
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 14, 2021
    Manufacturer
    CENTURION MEDICAL PRODUCTS CORP.
    Product Code
    OHG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) OLD PATIENT WAS HAVING A CIRCUMCISION. AFTER CIRCUMCISION WAS COMPLETE, THE PCP NOTICED THE CIRCUMCISION EQUIPMENT WAS SHREDDING THE SILVER LINING ONTO THE INFANTS' SKIN, HER GLOVES AND WHITE STERILE SHEET. NO HARM WAS NOTED TO NEWBORN. PACKAGING FOR PRODUCT NOT SAVED. LOT # AND EXPIRATION DATE LISTED IN THIS REPORT IS FOR ANOTHER IDENTICAL PRODUCT IN STOCK AT OUR HOSPITAL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902795 CENTURION CIRCUMCISION TRAY CIRCUMCISION TRAY OHG CENTURION MEDICAL PRODUCTS CORP. 21ABU612

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA