BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 4957791 · Received July 31, 2015

    Report

    Report Number
    3010757606-2015-00016
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH RECORD REVIEW WAS PERFORMED FOR THE LOT NUMBER PROVIDED. ALL PARAMETERS WERE WITHIN SPECIFICATIONS INCLUDING STERILIZATION CRITERIA. NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. THE BATCH RECORD REVIEW DID NOT IDENTIFY ANY PROBABLE OR ROOT CAUSES THAT WOULD CONTRIBUTE TO THE PATIENT'S CONDITION. THE ABBVIE TUBING IS PERFORMING AS EXPECTED. STOMA SITE INFECTION IS A KNOWN COMPLICATION OF A PEG TUBE PLACEMENT. A RETURN SAMPLE EVALUATION WAS NOT PERFORMED BECAUSE TUBING REMAINS IMPLANTED. THE CATALOG NUMBER PROVIDED IS THE DOMESTIC LIST NUMBER THAT IS COMPARABLE TO THE INTERNATIONAL LIST NUMBER IN THE "OTHER" FIELD. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A HEALTHCARE PROFESSIONAL IN (B)(6) REPORTED THAT A (B)(6) YEAR OLD PATIENT OBSERVED A YELLOW PURULENT DISCHARGE FROM THE PEG-J ENTRANCE (STOMA SITE). THE PEG TUBE WAS IMPLANTED ON (B)(6) 2015 AND ANTIBIOTIC DESEFIN WAS STARTED AS A PROPHYLAXIS. THE PATIENT WAS EXAMINED BY THE GASTROENTEROLOGIST WHO RECOMMENDED THE PATIENT CONTINUE HER ANTIBIOTIC THERAPY (DESEFIN 1GR 2 X 1 GR IV) FOR 5 MORE DAYS. THE DESEFIN TREATMENT WAS DISCONTINUED ON (B)(6) 2015 AND THE YELLOW PURULENT DISCHARGE WAS CONSIDERED RECOVERED ON (B)(6) 2015. DUODOPA TREATMENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499697 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32085225

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention LANSOPRAZOLE, RIVASTIGMINE, DESEFIN| MADOPAR, BACLOFEN, QUETIAPINE| AMANTADINE, DIOSMIN, VITAMIN COMPLEX