BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1052636 · Received May 27, 2008

    Report

    Report Number
    3005099803-2008-00557
    Event Type
    Injury
    Date Received
    May 27, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT AND DATE OF SLING IMPLANT IS NOT KNOWN. MODEL AND LOT NUMBER OF THE DEVICE USED IS UNKNOWN; CONSEQUENTLY, THE DEVICE MANUFACTURE AND EXPIRATION DATE IS NOT KNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. NO UPN WAS GIVEN FOR THIS DEVICE AND IT IS NOT KNOWN IF THE DEVICE WAS MANUFACTURED BY BSC. IF THE DEVICE WAS MANUFACTURED BY BSC, IT IS LIKELY TO HAVE BEEN A PRE-PUBIC SLING. THIS PRODUCT FAMILY CONSISTS OF 2 UPN NUMBERS: M0068506000 AND M0068506001. A SHIP HISTORY WAS PERFORMED ON EACH OF THE TWO POSSIBLE UPN NUMBERS. FOR M0068506000, THE LAST 3 LOTS SHIPPED TO THE CUSTOMER BEFORE THE AWARE DATE WAS 9756716, 9757646, AND 9589035. FOR M0068506001, THE LAST 3 LOTS SHIPPED TO THE CUSTOMER BEFORE THE AWARE DATE WAS 11077158, 9727647, AND 9665587. NO ISSUES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE FOUND IN THE DHR REVIEWS OF THE SIX IDENTIFIED LOTS SHIPPED TO THIS FACILITY. THE 2008 PRE-PUBIC SLING PRODUCT FAMILY TRENDING CHART WAS REVIEWED; AN UNFAVORABLE TREND WAS NOT NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNKNOWN SLING WAS IMPLANTED ON A DATE THAT WAS NOT PROVIDED. PATIENT AGE AND WEIGHT IS NOT KNOWN. POST PROCEDURE THE PHYSICIAN APPARENTLY NOTICED AN EXPOSURE. THE SLING WAS TRIMMED, REMOVING THE EXPOSED SLING MATERIAL. THE PATIENT HAS NOT SEEN THE PHYSICIAN SINCE THE REMOVAL OF THE EXPOSED SLING MATERIAL. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IT WAS REPORTED THAT THE PHYSICIAN STATED THAT SHE DID NOT KNOW IF IT WAS A BOSTON SCIENTIFIC SLING OR A COMPETITOR'S SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN FTL BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention