BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRATT RECTAL PROBE 10 IN SHAFT 7-3/4 IN

    MDR report key: 1880941 · Received October 5, 2010

    Report

    Report Number
    2523190-2010-00010
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 5, 2010
    Product Code
    EXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. CUSTOMER WILL NOT RELEASE DEVICE FOR INVESTIGATION. PHOTOGRAPHS REQUESTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS VIA MEDWATCH SUBMITTED TO MILTEX THAT A PT WAS UNDERGOING SURGICAL PROCEDURE FOR ANAL FISTULA. DURING THE PROCEDURE A RECTAL PROBE WAS USED AND THE DISTAL END OF PROBE BROKE OFF INTO THE PT. THE SURGEON WAS UNABLE TO RETRIEVE THE FOREIGN BODY AND IT REMAINS IN THE PT. THE FOREIGN BODY WAS CONFIRMED BY X-RAY. POST OPERATIVE X-RAY THE SAME DAY. THE USER REPORTS THE APPROXIMATE AGE OF DEVICE IS 6 YEARS. NO SERIOUS HARM TO PT PER CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRATT RECTAL PROBE 10 IN SHAFT 7-3/4 IN M17 - RECTAL EXX

    Patients

    Seq Age Sex Outcome Treatment
    1