BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1022831 · Received March 28, 2008

    Report

    Report Number
    2032545-2008-01650
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 ADD'L INFO 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 (03-DEC-2007).

    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 HANDLE/PLUNGER BROKE DURING THE PROCEDURE. 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 Q207015

    Patients

    Seq Age Sex Outcome Treatment
    1