BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

    MDR report key: 2213137 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02813
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 25, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER OR UPN; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DEVICE (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF HOLE IN PEG TUBE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISPOSED OF; 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 INITIAL PLACEMENT PEG KIT (EXACT UPN IS UNKNOWN) WAS USED DURING A PROCEDURE (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, ON (B)(6) 2011 THERE WAS A HOLE IN THE PEG TUBE NEAR THE SECTION THAT PENETRATES THE SKIN. ON (B)(4) 2011 THE TUBE WAS REPLACED WITH A NEW ENDOVIVE INITIAL PLACEMENT PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK518

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other