BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUODOPA_DUOPA

    MDR report key: 13573195 · Received February 21, 2022

    Report

    Report Number
    3010757606-2022-00104
    Event Type
    Death
    Date Received
    February 21, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 21, 2022
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (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 NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. ASPIRATION PNEUMONIA AND SUSPECTED GASTRIC PERFORATION ARE KNOWN COMPLICATIONS OF A PEG- J TUBE PLACEMENT. (B)(4). IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER (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 NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. ASPIRATION PNEUMONIA AND SUSPECTED GASTRIC PERFORATION ARE KNOWN COMPLICATIONS OF A PEG- 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 · 0

    ON (B)(6) 2022, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE PATIENT EXPERIENCED ASPIRATION PNEUMONIA AND SUSPECTED GASTRIC PERFORATION. ON UNKNOWN DATE, THE PATIENT DIED. THE NEUROLOGIST REPORTED THE DEATH OF THE PATIENT CAUSED BY ASPIRATION PNEUMONIA AND SUSPECTED GASTRIC PERFORATION POST POSITIONING OF THE DEVICE PEG J TUBE. HE HAD NOT STARTED TREATMENT WITH DUODOPA. THE NEUROLOGIST STATED THE DEATH WAS NOT RELATED TO THE PEG/J TUBING NOR TO THE DEVICE PLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE PATIENT EXPERIENCED ASPIRATION PNEUMONIA AND SUSPECTED GASTRIC PERFORATION. ON UNKNOWN DATE, THE PATIENT DIED. THE NEUROLOGIST REPORTED THE DEATH OF THE PATIENT CAUSED BY ASPIRATION PNEUMONIA AND SUSPECTED GASTRIC PERFORATION POST POSITIONING OF THE DEVICE PEG J TUBE. HE HAD NOT STARTED TREATMENT WITH DUODOPA. THE NEUROLOGIST STATED THE DEATH WAS NOT RELATED TO THE PEG/J TUBING NOR TO THE DEVICE PLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224716 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R J TUBE, UNKNOWN MANUFACTURER