BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1061793 · Received June 13, 2008

    Report

    Report Number
    2032545-2008-03223
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 14, 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
    OTHER

    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 INFORMATION IS RECEIVED FROM THE HCP. THE DEVICE IS INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYSTEM 9012B1011 (5-PACK) AND 9012B1001 (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION (2007).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. IT WAS DIFFICULT TO POP UP THE PLUNGER. UPON REMOVAL OF THE DEVICE FROM THE PATIENT THE CAPSULE WAS STILL ATTACHED TO THE DELIVERY SYSTEM AND SUBSEQUENTLY FELL ONTO THE FLOOR. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q218787

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK