BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO

    MDR report key: 1051635 · Received May 21, 2008

    Report

    Report Number
    2032545-2008-02697
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYSTEM (5-PACK) AND (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION.

    Description of Event or Problem · 1

    SEE MANUFACTURING # 2032545200802695 AND 2032545200802694. THIS WAS THE THIRD CAPSULE ATTEMPTED FOR THIS PATIENT. WHILE PLACING THE BRAVO PH MONITOR THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE CAPSULE FELL ONTO THE FLOOR. IT WAS NOTED THAT THE TISSUE WAS RED AND SLIGHTLY BLEEDING. THE PHYSICIAN INJECTED IT WITH EPINEPHRINE AND THE PATIENT WAS DISCHARGED WITHOUT AN EVENT. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT HAS NOT BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q220442

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention