BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 6915211 · Received October 5, 2017

    Report

    Report Number
    3010757606-2017-00458
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 8, 2017
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD 1083871. 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

    ON AN UNKNOWN DATE, PATIENT UNDERWENT PROCEDURE FOR PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. TWO DAYS AFTER THE PROCEDURE, THE PATIENT BEGAN TO HAVE STOMA REDNESS AND DRAINAGE AND DEVELOPED STOMA SITE INFECTION. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS AND THE STOMA HAS NOT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696694 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention J TUBE - MANUFACTURER UNK