BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT¿

    MDR report key: 2340657 · Received November 17, 2011

    Report

    Report Number
    3005099803-2011-03951
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    May 16, 2011
    Report Date
    October 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INTERJECT INJECTION THERAPY NEEDLE WOULD NOT EXTEND, AND WOULD NOT INJECT MEDICINE. PRESSURE WAS FELT WHILE ATTEMPTING TO ADMINISTER THE MEDICINE. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. 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 INTERJECT¿ KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518151 14003825

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR