BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODOPA_DUOPA

    MDR report key: 9158023 · Received October 4, 2019

    Report

    Report Number
    3010757606-2019-00678
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    September 9, 2019
    Report Date
    September 9, 2019
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE RECORD (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2017 A PATIENT IN SWITZERLAND UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE AND A JEJUNAL (PEG-J) TUBE ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF (B)(4). THE Y-ADAPTOR AND 2 SECTIONS OF J-TUBING WERE RETURNED. A VISUAL INSPECTION WAS PERFORMED. A BEZOAR WAS OBSERVED AT THE END OF THE J-TUBING, COVERING THE PIG TAIL. THE BEZOAR WAS A SOLID THREE-DIMENSIONAL MASS OF FIBROUS MATERIAL. NO APPARENT DAMAGE WAS OBSERVED TO THE VISIBLE PORTIONS OF THE J TUBING. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT IN SWITZERLAND UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE AND A JEJUNAL (PEG-J) TUBE ON (B)(6) 2017. ON (B)(6) 2019 A NEW PEJ TUBE WAS PLACED DUE TO THE OLD PEJ TUBE PROTRUDES ONLY 10 CM FROM THE STOMA AND SLIPS REPEATEDLY. THE STOMA SITE WAS PAINLESS BUT SLIGHTLY RED AND HARD AT INCISION SITE. UPON REMOVAL IT WAS NOTED THE OLD PEJ TUBE HAD A LARGE BEZOAR AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950257 DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 32384204

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ABBVIE PEG TUBE, LOT # 32294374