BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 13182132 · Received January 6, 2022

    Report

    Report Number
    3010757606-2022-00006
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 20, 2021
    Report Date
    January 6, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A BEZOAR IS A KNOWN COMPLICATION OF A J-TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A BEZOAR IS A KNOWN COMPLICATION OF A J-TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. A NURSE REPORTED ON (B)(6) 2021, THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. AN X-RAY REVEALED A "SMALL MASS IN THE PIG TAIL AREA." ON (B)(6) 2021, THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE J-TUBE WHERE A BEZOAR WAS OBSERVED. NO DAMAGE IS OBSERVED IN THE GASTRIC MUCOSA.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. A NURSE REPORTED ON (B)(6) 2021, THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN. AN X-RAY REVEALED A "SMALL MASS IN THE PIG TAIL AREA." ON (B)(6) 2021, THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE J-TUBE WHERE A BEZOAR WAS OBSERVED. NO DAMAGE IS OBSERVED IN THE GASTRIC MUCOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898479 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention ABBVIE PEG TUBELOT # 32361129