BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIOS

    MDR report key: 3840179 · Received May 23, 2014

    Report

    Report Number
    MW5036338
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 19, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BALLOON ON END OF TROCAR WOULD NOT DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307119 FIOS TROCAR DRC APPLIED MEDICAL CFB03

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other