BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICK H.A.M. APPLICATOR

    MDR report key: 551129 · Received October 21, 2004

    Report

    Report Number
    551129
    Event Type
    Other
    Date Received
    October 21, 2004
    Date of Event
    September 23, 2004
    Report Date
    October 21, 2004
    Manufacturer
    MICK RADIO-NUCLEAR INSTRUMENTS, INC.
    Product Code
    KXK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT THE FOLLOWING PROCEDURE: EXCISION OF FISTULOUS TRACT, WITH DEBRIDEMENT, FISTULOUS TRACT DIMENSIONS 4X2X9, WITH CURETTAGE IRRIGATION, PLACEMENT OF VACUUM-ASSISTED CLOSURE DEVICE DRESSING. DURING THE PROCEDURE, IT WAS NOTED THAT "A WHITE, SMALL APPROXIMATELY 4MM BEAD-LIKE STRUCTURE APPEARED AT THE BASE OF THE FISTULA. THIS WAS CONSISTENT WITH A BRACHYTHERAPY CATHETER. THIS WAS REMOVED AND SENT FOR PATHOLOGIC EVALUATION." IT WAS LATER DETERMINED THAT THIS WAS A BEAD FROM A HAM APPLICATOR MANUFACTURED BY MICK RADIO-NUCLEAR INSTRUMENTS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICK H.A.M. APPLICATOR BRACHYTHERAPY MULTIPLE CATHETER APPLICATOR KXK MICK RADIO-NUCLEAR INSTRUMENTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR OTHER