BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1945096 · Received January 3, 2011

    Report

    Report Number
    3005099803-2010-05453
    Event Type
    Injury
    Date Received
    January 3, 2011
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT IS IMPLANTED; 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 (EXACT MODEL NUMBER IS UNKNOWN) WAS PLACED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST PROCEDURE APPROXIMATELY SOME TIME IN (B)(6), THE NURSE REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING GRANULOMA. SINCE (B)(6) 2010, THE PATIENT HAS BEEN TREATED WITH LAPIS (SILVER NITRATE), DERMOVAT OINTMENT AND CAVILON OINTMENT ALONG WITH A SORBACT BANDAGE. 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. ADDITIONAL INFORMATION RECEIVED ON JANUARY 17, 2011: THE PARKINSON'S NURSE STATED THE RELATIONSHIP BETWEEN THE PEG DEVICE AND THE NON-SERIOUS GRANULOMA IS THAT WITHOUT THE PEG DEVICE THE GRANULOMA WOULD NOT EXIST HOWEVER THE GRANULOMA IS NOT RELATED TO THE BRAND OF PEG DEVICE. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT (EXACT MODEL NUMBER IS UNKNOWN) WAS PLACED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, POST PROCEDURE APPROXIMATELY SOME TIME IN MID-(B)(6), THE NURSE REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING GRANULOMA. SINCE (B)(6), 2010 THE PATIENT HAS BEEN TREATED WITH LAPIS (SILVER NITRATE), DERMOVAT OINTMENT AND CAVILON OINTMENT ALONG WITH A SORBACT BANDAGE. 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
    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 Other DUODOPA