BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENNIUM PRATT RECTAL PROBE 73/4 SILVER

    MDR report key: 16312191 · Received February 6, 2023

    Report

    Report Number
    MW5114735
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 2, 2023
    Manufacturer
    MILLENNIUM / INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS.
    Product Code
    KOA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PIECE OF THE RECTAL PROBE BROKE OFF DURING A RECTAL EXAM UNDER ANESTHESIA. THE PIECE WAS FOUND AND REMOVED FROM THE PT'S RECTUM. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115958 MILLENNIUM PRATT RECTAL PROBE 73/4 SILVER SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) KOA MILLENNIUM / INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS. 1-475335 508230(2)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention