BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1062344 · Received June 18, 2008

    Report

    Report Number
    2032545-2008-03336
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE DID NOT ATTACH TO THE PT'S ESOPHAGUS. THE PT SPIT-UP THE CAPSULE. NO SERIOUS INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q220192

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK