BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1022887 · Received March 28, 2008

    Report

    Report Number
    2032545-2008-01628
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP.

    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 PHYSICIAN NOTED THAT THERE WAS MORE THAN USUAL RESISTANCE WHEN PUSHING THE PLUNGER DOWN. THE PHYSICIAN WAS ABLE TO ROTATE THE PLUNGER, BUT NEEDED TO PULL UP ON IT. THE PT FELT DISCOMFORT IN THE MIDDLE OF THEIR CHEST. AN EGD CONFIRMED THE CAPSULE HAD FALLEN OFF INTO THE PT'S STOMACH. 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 Q216336

    Patients

    Seq Age Sex Outcome Treatment
    1