BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND MULTIPLE BAND LIGATOR

    MDR report key: 845121 · Received May 3, 2007

    Report

    Report Number
    6000048-2007-00156
    Event Type
    Injury
    Date Received
    May 3, 2007
    Report Date
    April 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MND
    PMA / PMN Number
    k990864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. A DHR REVIEW WAS CONDUCTED ON LOTS 9437632, 8900563 AND 8929913, THE LAST THREE LOTS SHIPPED TO THE CUSTOMER BEFORE THE AWARE DATE. THE REVIEW REVEALED NO ANOMALIES THAT COULD BE ASSOCIATED WITH THIS INCIDENT. A LOT HISTORY SEARCH COULD NOT BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. A COMPLAINT REVIEW WAS CONDUCTED ON LOTS 9437632, 8900563, AND 8929913. NO COMPLAINTS HAVE BEEN REPORTED FROM ANY OF THE 3 LOTS. THE MARCH 2007 ROLLING 15 MONTH TREND CHART WAS REVIEWED FOR THE BAND LIGATION PRODUCT FAMILY AND REVEALED NO ADVERSE TRENDS. ADDITIONALLY, THE TOTAL NUMBER OF COMPLAINTS RECEIVED FOR THIS PRODUCT FAMILY DOES NOT EXCEED A LIMIT WHICH WOULD WARRANT FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE DURING WHICH BAND LIGATION WAS PERFORMED IN ORDER TO TREAT ESOPHAGEAL VARICES USING A BSC SPEEDBAND MULTIPLE BAND LIGATOR DEVICE. IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT RETURNED TO FACILITY WITH THE LIGATION BANDS "IN HER HAND". THE PATIENT WAS REPORTED TO HAVE VOMITED AND EXPELLED THE BANDS. BLEEDING EXPERIENCED AT THAT TIME WAS STOPPED BY THE PATIENT. THE PATIENT WAS SCHEDULED TO UNDERGO ADDITIONAL BANDING TREATMENT TO REPLACE THE BANDS THAT WERE EXPELLED. NO OTHER COMPLICATIONS OR ILL EFFECTS WERE REPORTED TO HAVE OCCURRED FOLLOWING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND MULTIPLE BAND LIGATOR MND MND BOSTON SCIENTIFIC M00542251 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention