BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, 20 FR

    MDR report key: 6612883 · Received June 5, 2017

    Report

    Report Number
    2025851-2017-00001
    Event Type
    Injury
    Date Received
    June 5, 2017
    Report Date
    April 18, 2017
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    KNT
    PMA / PMN Number
    K083684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS ESTIMATED MINIMUM BASED ON DESCRIPTION AS ELDERLY. MODEL NUMBER IS THE XERIDIEM PART NUMBER FOR THE REPORTED PRODUCT. CATALOG NUMBER IS CORRESPONDING PART NUMBER FOR BOSTON SCIENTIFIC CORPORATION, THE EXCLUSIVE DISTRIBUTOR FOR THE PRODUCT. DEVICE WAS NOT RETURNED FOR EVALUATION SO A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SOLICITED REPORT FROM (B)(6) BY A CONSUMER OF AN ELDERLY MALE WITH AN EVENT OF NON-SERIOUS STOMA INFECTION WITH DUODOPA (LEVODOPA/CARBIDOPA). THE PATIENT HAD A RELEVANT MEDICAL HISTORY OF ADVANCED PARKINSON'S DISEASE. IN (B)(6) 2017, THE PATIENT EXPERIENCE STOMA INFECTION. CURRENTLY THE PATIENT CONTINUES RECEIVING DUODOPA THROUGH THE NASAL J-TUBE. TJE [ATOEMT JAD A PEG PERFORMED BY RADIOLOGIST, WHO ON (B)(6) 2017, PLACED A BALLOON PEG TUBE INSTEAD OF THE DUODOPA PEG. THE PATIENT WAS WAITING TO HAVE THE BALLOON PEG TUBE REPLACED BY THE DUODOPA PEG TUBE. THE PATIENT WAS TREATED WITH AMOXICILLIN/CLAVULANIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392082 ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, 20 FR GASTROSTOMY FEEDING TUBE KNT XERIDIEM MEDICAL DEVICES 70-0023-020 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention