BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4203

    MDR report key: 2083383 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01641
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE WAS USED DURING A BAND LIGATION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER AN ATTEMPTED BAND LIGATION, A HEMATOMA FORMED AND THE PHYSICIAN WAS CONCERNED AS THIS MAY CAUSE GASTROINTESTINAL BLEEDING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE WAS USED DURING A BAND LIGATION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER AN ATTEMPTED BAND LIGATION, A HEMATOMA FORMED AND THE PHYSICIAN WAS CONCERNED AS THIS MAY CAUSE GASTROINTESTINAL BLEEDING. 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 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4203 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542250 13044439

    Patients

    Seq Age Sex Outcome Treatment
    1 Other