BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1972844 · Received January 28, 2011

    Report

    Report Number
    3005099803-2011-00090
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, WITHIN ONE MONTH (EXACT DATE IS UNKNOWN) AFTER THE REPLACEMENT OF THE BUTTON THE CAP ON THE BUTTON WAS UNABLE TO CLOSE. THIS DEVICE IS CURRENTLY IMPLANTED AND IS SCHEDULED TO BE REPLACED. TO DATE IT HAS NOT BEEN REPLACED.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.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 BUTTON REPLACEMENT GASTROSTOMY DEVICE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568290 13700981

    Patients

    Seq Age Sex Outcome Treatment
    1