BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 4218923 · Received September 30, 2014

    Report

    Report Number
    9710107-2014-00205
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 28, 2014
    Manufacturer
    IVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE IN THIS CASE. THE INFORMATION WAS UPDATED IN THIS SUPPLEMENTAL.

    Description of Event or Problem · 1

    A REPEAT PROCEDURE WAS NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. INTERVENTION WAS NOT REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE ESOPHAGUS APPEARED TO BE NORMAL. THE DEVICE OPERATOR HAS BEEN PERFORMING THIS PROCEDURE FOR FIVE YEARS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO ATTACH. THE PT WAS NOT INJURED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607518 BRAVO BRAVO PH CAPSULE FFT IVEN IMAGING LTD. FGS-0313 25143Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention