BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO PH MONITORING SYSTEM

    MDR report key: 2426052 · Received January 19, 2012

    Report

    Report Number
    MW5023904
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 19, 2012
    Manufacturer
    GIVEN IMAGING, LTD
    Product Code
    FFT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THREE BRAVO PH CAPSULES FROM GIVEN IMAGING, LTD FROM LOT# 16867Q FAILED TO ATTACHED TO ESOPHAGUS AND/OR DETACHED AFTER PLACEMENT. TWO CAPSULES WERE RETRIEVED FROM PT'S STOMACH AND SENT TO MFR, GIVEN IMAGING, FOR DIAGNOSTIC. THIRD CAPSULE DISLODGED AFTER ENDOSCOPY WAS COMPLETED, AND PT WAS DISCHARGED HOME, AND WAS NOT RETRIEVED. DATES OF USE: (B)(6) 2012 - (B)(6) 2012 AND (B)(6) 2012 - (B)(6) 2012. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO PH MONITORING SYSTEM BRAVO CAPSULE FFT GIVEN IMAGING, LTD 16867Q
    2 BRAVO PH MONITORING SYSTEM BRAVO CAPSULE FFT GIVEN IMAGING, LTD 16867Q
    3 BRAVO PH MONITORING SYSTEM BRAVO CAPSULE FFT GIVEN IMAGING, LTD 16867Q

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR