BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PROFLEX 273 LASER LITHOTRIPSY FIBER

    MDR report key: 7337427 · Received March 13, 2018

    Report

    Report Number
    MW5075847
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    March 12, 2018
    Report Date
    March 12, 2018
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BARD PRO-FLEX 273 LASER LITHOTRIPSY FIBER BROKE WHILE IN USE AND LANDED ON DOCTOR'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179623 BARD PROFLEX 273 LASER LITHOTRIPSY FIBER POWERED LASER SURGICAL GEX INNOVAQUARTZ LLC 26317001

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR