BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIVERY DEVICE

    MDR report key: 4999225 · Received August 11, 2015

    Report

    Report Number
    9710107-2015-00209
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 10, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BRAVO CAPSULE FAILED TO ATTACH. THERE WAS NO HARM TO THE PT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524881 BRAVO PH CAPSULE DELIVERY DEVICE BRAVO FFT GIVEN IMAGING LTD. FGS-0313

    Patients

    Seq Age Sex Outcome Treatment
    1