BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 10968473 · Received December 8, 2020

    Report

    Report Number
    3010757606-2020-00769
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    November 1, 2020
    Report Date
    December 7, 2020
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED AND WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED.   A BEZOAR IS A KNOWN COMPLICATION OF A J-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) 2020, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE (J-TUBE). IN NOV 2020, THE PATIENT EXPERIENCED NAUSEA AND VOMITING. ON (B)(6) 2020. ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A BEZOAR AND PRESSURE ULCERS VIA GASTROSCOPY. THE MEDICAL DOCTOR DETERMINED THAT THE DEVELOPMENT OF GASTRIC AND DUODENAL ULCERS WERE DUE TO THE TENSION OF BEZOAR TO THE TUBE. ON AN UNKNOWN DATE, THE J TUBE WAS REMOVED AND REPLACED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433813 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32224287

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention UNKNOWN PEG TUBE, LOT # UNKNOWN