BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 13584122 · Received February 23, 2022

    Report

    Report Number
    3010757606-2022-00113
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    January 30, 2022
    Report Date
    February 22, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062912. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. GASTRIC ULCER IS A KNOWN COMPLICATION OF A PEG 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 062912. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. GASTRIC ULCER IS A KNOWN COMPLICATION OF A PEG 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 KUWAIT UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. THE PATIENT EXPERIENCED ABDOMINAL PAIN ON (B)(6) 2022. A CT SCAN WITH DYE WAS PERFORMED AND THE PHYSICIAN OBSERVED PERITONEAL FLUID COLLECTION AND A PERFORATED PEPTIC ULCER NEAR THE STOMA SITE. THE PEPTIC ULCER WAS REPAIRED WITH SURGERY AND THE PEG/J TUBES WERE REMOVED UNTIL FURTHER ASSESSMENT.

    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. THE PATIENT EXPERIENCED ABDOMINAL PAIN ON (B)(6) 2022. A CT SCAN WITH DYE WAS PERFORMED AND THE PHYSICIAN OBSERVED PERITONEAL FLUID COLLECTION AND A PERFORATED PEPTIC ULCER NEAR THE STOMA SITE. THE PEPTIC ULCER WAS REPAIRED WITH SURGERY AND THE PEG/J TUBES WERE REMOVED UNTIL FURTHER ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148389 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32221150

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization| R ABBVIE J-TUBELOT #32192100