BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1040417 · Received May 7, 2008

    Report

    Report Number
    3005099803-2008-00438
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE REVEALED ONE ADDITIONAL COMPLAINT REPORTED FOR THE SAME LOT (SEE ASSOCIATED MANUFACTURER REPORT #3005099803-2008-00437). THE MARCH 2008 15-MONTH BAND LIGATION PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO ADVERSE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTES: THIS REPORT PERTAINS TO THE SECOND OF TWO MALFUNCTIONS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MFR REPORT #3005099803-2008-00437 FOR DETAILS REGARDING THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AFTER THE LIGATOR BAND FROM THE FIRST DEVICE FELL OFF THE VARIX, A SECOND SPEEDBAND SUPERVIEW SUPER 7 LIGATOR DEVICE WAS USED; AGAIN, THE LIGATOR BAND FELL OFF THE VARIX. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN COMPLETED THE PROCEDURE USING SCLEROTHERAPY (UNKNOWN DEVICE AND MANUFACTURER). AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542253 0011202925

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK