BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA SLING KIT STANDARD

    MDR report key: 1032799 · Received April 23, 2008

    Report

    Report Number
    3005099803-2008-00372
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K932925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY THE DEVICE EXPIRATION DATE IS UNKNOWN. SINCE THE DEVICE REMAINS IMPLANTED A FAILURE ANALYSIS WILL NOT BE POSSIBLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. THE PRODUCT FOR THIS COMPLAINT WAS RECALLED BY BOSTON SCIENTIFIC CORPORATION IN 1999. A REVIEW OF THE SPECIFIC DEVICE HISTORY RECORD AND LOT HISTORY SEARCH COULD NOT BE CONDUCTED DUE THE LOT NUMBER BEING UNKNOWN. NO PRODUCT FAMILY TREND REVIEW COULD BE CONDUCTED. THIS PRODUCT IS NOT PART OF ANY PRODUCT FAMILY. A COMPLAINT REVIEW FOR THE REPORTED UPN WAS CONDUCTED. NO OTHER COMPLAINT FOR THIS UPN NUMBER HAS BEEN RECORDED. THERE IS NOT ENOUGH INFORMATION IN THE COMPLAINT DESCRIPTION, OR RESULTS FROM DEVICES RETURNED FOR SIMILAR ISSUES TO MAKE ANY ASSUMPTIONS ABOUT THE FAILURE MODE OF THE PRODUCT. NO CONCLUSIONS COULD BE DRAWN REGARDING THE POSSIBLE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, BY THE PATIENT (WEIGHT IS UNKNOWN), THAT IN 1997, SHE UNDERWENT A PLACEMENT OF A VESICA SLING FOR AN OVERACTIVE BLADDER AT HOSPITAL. SHE ALSO REPORTED THAT ON THE MORNING OF 2008, SHE BEGAN HAVING A VAGINAL DISCHARGE, A FEVER, AND LOST CONTROL OF HER BLADDER. HER PHYSICIAN WAS CONTACTED AND REPORTS THAT THIS PATIENT WAS SEEN IN THE SAME MONTH, FOR ABDOMINAL PAIN. AN ULTRASOUND CONFIRMED OVARIAN CYSTS. THEY ALSO CONFIRM THAT THE PATIENT DOES HAVE A BLADDER PROLAPSE BUT THERE IS NO VAGINAL EROSION PRESENT. A URINALYSIS INDICATES BLOOD IN THE URINE WITH NO BACTERIA. THE PATIENT CLAIMS SHE IS FEBRILE AND TAKING AMOXICILLIN 875 MG. THE PHYSICIAN'S OFFICE INDICATED THAT THE PATIENT IS NOT FEBRILE AND UNAWARE OF HER BEING PRESCRIBED ANTIBIOTICS. THE PHYSICIAN'S OFFICE ALSO REPORTS THAT CURRENTLY THERE ARE NO PLANS IN PLACE FOR FURTHER TREATMENT AND THEY HAVE NO HISTORY REGARDING THE TIMEFRAME BETWEEN PLACEMENT OF THE SLING AND WHEN SHE WAS SEEN IN THEIR OFFICE IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESICA SLING KIT STANDARD FTL BOSTON SCIENTIFIC CORPORATION M0068201110 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention