BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO PH CAPSULE DELIVERY DEVICE

    MDR report key: 5107009 · Received September 26, 2015

    Report

    Report Number
    9710107-2015-00234
    Event Type
    Injury
    Date Received
    September 26, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 26, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD BRAVO CAPSULE PLACED SIX DAYS BEFORE PRESENTING TO EMERGENCY ROOM WITH CHEST PAIN. REPEAT ENDOSCOPY SHOWED CAPSULE IN PLACE IN THE ESOPHAGUS. NO UNUSUAL FINDINGS WERE NOTED. PHYSICIAN REMOVED CAPSULE WITH MILD NUDGING OF THE ENDOSCOPE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637308 BRAVO PH CAPSULE DELIVERY DEVICE BRAVO FFT GIVEN IMAGING LTD. FGS-0313

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O