BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO PH CAPSULE DELIVERY DEVICE

    MDR report key: 4152618 · Received October 2, 2014

    Report

    Report Number
    MW5038516
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 2, 2014
    Manufacturer
    GIVEN IMAGING
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS DEPLOYED BY MD USING PROPER TECHNIQUE. MD RESCOPED EGD PT TO EVALUATE PROPER PLACEMENT OF PROBE IN ESOPHAGUS. PROBE WAS NOT ATTACHED. UPON FURTHER EVALUATION, PROBE WAS FOUND FLOATING NEAR VOCAL CORDS. RETRIEVED EMERGENTLY WITH NET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614464 BRAVO PH CAPSULE DELIVERY DEVICE BRAVO FFT GIVEN IMAGING 2014-06/256942

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention