BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 11008307 · Received December 15, 2020

    Report

    Report Number
    3010757606-2020-00789
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 23, 2020
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (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) 2020, REPORTER PROVIDED PRODUCT INFORMATION, ABBVIE 15FR LOT PEG LOT 32341129 AND LOT J TUBE 32371119.

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4).   THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED AND THE DEVICE DISPOSITION IS UNKNOWN; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. HOWEVER, IF THE DEVICE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE RETURN SAMPLE INVESTIGATION.   A GASTRIC ULCER 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 · 1

    ON (B)(6) 2019, A PATIENT UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC JEJUNAL TUBE (J-TUBE). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN. ON (B)(6) 2020, THE PATIENT'S J TUBE WAS REMOVED SUE TO GASTRIC ULCERS. THE PATIENT WILL BE REEVALUATED IN EIGHT WEEKS TO DETERMINE IF THE ULCERS HAVE HEALED AND IF J TUBE REINSERTION WILL TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478939 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32371119

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ABBVIE PEG TUBE, LOT # 32341129| UNKNOWN PEG TUBE, LOT # UNKNOWN| UNKNOWN PEG TUBE, LOT # UNKNOWN