BEUDAMED
    FDA Adverse Event Other Summary report: N

    LATEX-FREE BRACHYBALLOON

    MDR report key: 478152 · Received August 11, 2003

    Report

    Report Number
    1937223-2003-00003
    Event Type
    Other
    Date Received
    August 11, 2003
    Date of Event
    July 6, 2003
    Report Date
    August 8, 2003
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE BALLOON BURST INSIDE THE PT WHEN FITTED TO AN ENDOCAVITY TRANSDUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATEX-FREE BRACHYBALLOON STANDOFF ITX CIVCO MEDICAL INSTRUMENTS CO., INC. 3000A02 M518830

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other