BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE¿ STANDARD PEG KIT

    MDR report key: 5433522 · Received February 12, 2016

    Report

    Report Number
    3005099803-2016-00228
    Event Type
    Injury
    Date Received
    February 12, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE PATIENT EXPERIENCED AN INFECTION ON THE PEG STOMA SITE. ORAL ANTIBIOTIC TREATMENT WAS STARTED WITH AUGMENTIN BID 1GR, 3X1. THE PATIENT IS ABLE TO PERFORM MODERATE ACTIVITIES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE PATIENT EXPERIENCED AN INFECTION ON THE PEG STOMA SITE. ORAL ANTIBIOTIC TREATMENT WAS STARTED WITH AUGMENTIN BID 1GR, 3X1. THE PATIENT IS ABLE TO PERFORM MODERATE ACTIVITIES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90095 ENDOVIVE¿ STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568380 15394361

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other