BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEGJ

    MDR report key: 7120633 · Received December 14, 2017

    Report

    Report Number
    MW5073975
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ABBVIE INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED TO START DUOPA. SHE UNDERWENT SUCCESSFUL ENDOSCOPIC PLACEMENT OF AN ABBVIE PEG-J ON (B)(6) WITHOUT COMPLICATION. SHE PRESENTED TO THE ED ON (B)(6) WITH FEVERS AND ABDOMINAL PAIN AND WAS FOUND TO BE IN SEPTIC SHOCK. IMAGING REVEALED A HEPATIC ABSCESS WHICH WAS DRAINED. CULTURE WAS MULTIMICROBIAL. BLOOD CULTURES REVEALED BACTEREMIA WITH STREPTOCOCCUS ANGINOSUS. PATIENT WENT INTO AFIB WITH RVR, WHICH WAS TREATED AND SHE RETURNED TO NSR. J TUBE WAS FOUND TO BE BLOCKED. KEOFEED WAS PLACED WHICH RESULTED IN SIGNIFICANT EPISTAXIS REQUIRING INTUBATION FOR AIRWAY PROTECTION. ADDITIONALLY, AS A RESULT OF THE ABOVE, PATIENT WAS NOT GIVEN HER REQUIRED PARKINSON'S MEDICATIONS FOR 6 DAYS. PATIENT CONTINUES TO BE INPATIENT. PLAN IS TO REMOVE GJ TUBE ONCE SHE IS MEDICALLY STABLE AND ONCE TRACT MATURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899260 PEGJ PEGJ IN PREPARATION FOR DUOPA KNT ABBVIE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L