BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6893491

    MDR report key: 6893491 · Received September 26, 2017

    Report

    Report Number
    6893491
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 1, 2017
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BRAVO PH MONITORING CAPSULE WAS NOT IN THE AREA EXPECTED WHEN THE ENDOSCOPE WAS INSERTED TO CONFIRM PLACEMENT. THE PHYSICIAN WAS UNABLE TO DETERMINE THE REASON THE BRAVO PH MONITORING CAPSULE DID NOT ATTACH TO THE ESOPHAGUS. THE BRAVO PH MONITORING CAPSULE WAS VISIBLE IN THE BACK OF THE THROAT AND WAS RETRIEVED BY THE PHYSICIAN. ANOTHER BRAVO PH MONITORING CAPSULE WAS PREPARED AND ATTACHED TO THE ESOPHAGUS. NO UNTOWARD PATIENT EFFECTS.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR