BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBES

    MDR report key: 1377961 · Received May 7, 2009

    Report

    Report Number
    3005099803-2009-02300
    Event Type
    Injury
    Date Received
    May 7, 2009
    Date of Event
    April 10, 2009
    Report Date
    April 10, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K961345
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT #; THEREFORE, THE DEVICE EXP AND MFR DATES ARE UNK. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT OF DEVICE AND COMPLETION OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE DEVICE WAS PLACED IN 2008. PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. PER THE COMPLAINANT, APPROXIMATELY 6 MONTHS AFTER PLACEMENT, THE INTERNAL BUMPER CAME OFF AND THE TUBE WAS REMOVED FROM THE PT'S BODY. IT WAS THE PHYSICIAN'S OPINION THAT THE INTERNAL BUMPER WOULD PASS NATURALLY. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S STATUS WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBES KNT BOSTON SCIENTIFIC CORPORATION M00568151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other