BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 6254524 · Received January 16, 2017

    Report

    Report Number
    3010757606-2017-00015
    Event Type
    Injury
    Date Received
    January 16, 2017
    Date of Event
    December 26, 2016
    Report Date
    December 26, 2016
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION ADDED TO DESCRIBE EVENT OR PROBLEM AND RELEVANT TESTS/LAB DATA. SUBSEQUENT TO THE SUBMISSION OF THE INITIAL MEDWATCH REPOT, IT WAS NOTED THAT THE PEG IMPLANT DATE WAS INADVERTENTLY NOT INCLUDED; DATA ADDED TO IMPLANT DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062941-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED, WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. STOMA SITE INFECTION 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 · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE STOMA SITE WAS OOZING SINCE (B)(6) 2017. ON (B)(6)2017, THE PATIENT WAS SEEN IN EMERGENCY DEPARTMENT FOR QUESTIONABLE URINARY TRACT INFECTION AND STOMA SITE INFECTION. THE PATIENT WAS PRESCRIBED CALVAPEN 666 MG ORALLY QDS FOR 5 DAYS, AND FLUCLOXACILLIN 500 MG QDS ORALLY FOR 5 DAYS. THE STOMA SITE REDNESS MUCH IMPROVED ON THE (B)(6) 2017 WITH LESS OOZE. THERE WAS NO INTERRUPTION TO DUOPA THERAPY.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT IN (B)(6) UNDERWENT PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. ON (B)(6) 2016, THE PATIENT WAS ADMITTED DUE TO PAIN AND INCREASING REDNESS TO STOMA SITE. THE PATIENT WAS TREATED WITH 2 DOSES OF IV ANTIBIOTICS, BENZOPENICILLIN 1.2GM AND FLUCLOXACILLIN 1GM. THE STOMA SITE REDNESS WAS IMPROVED AND PATIENT WAS DISCHARGED HOME. THE REPORT ON (B)(6) 2016 STATED, THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS OF FLUCLOXACILLIN 500MG QDS AND KOPEN 500MG QDS FOR ONE WEEK. THERE WAS NO INTERRUPTION TO DUODOPA THERAPY. THERE WAS GOOD IMPROVEMENT TO STOMA SITE REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37773 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE 32495235

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ABBVIE J TUBE 32485285