BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 12099952 · Received July 1, 2021

    Report

    Report Number
    3010757606-2021-00449
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 1, 2021
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062910. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED AND WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. BURIED BUMPER AND STOMA SITE INFECTION ARE KNOWN COMPLICATIONS OF A PEG TUBE PLACEMENT. (B)(4). IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2021 THE PATIENT EXPERIENCED A STOMA SITE INFECTION WITH GRANULATION TISSUE TO THE AFFECTED SITE. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR THE EVENT OF INTERNAL RETENTION PLATE OF PEG TUBE BECAME VISIBLE FROM THE OUTSIDE. THE PATIENT HAD PG-J REPLACED ON THE SAME DAY AND WAS TREATED WITH ORAL ANTIBIOTICS FOR STOMA SITE INFECTION; AUGMENTIN 1000 MG TWICE DAILY AND CIPROFLOXACIN 500 MG TWICE DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996128 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32464267

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R ABBVIE J-TUBE, LOT # 32041278