BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1871885 · Received October 16, 2010

    Report

    Report Number
    3005099803-2010-04404
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS NOT AVAILABLE BUT IS REPORTEDLY OVER 18 YEARS OLD. THERE IS NO PATIENT CODE FOR CATHETERIZATION. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    'DESCRIBE EVENT OR PROBLEM' HAS BEEN UPDATED WITH ADDITIONAL INFORMATION AND CORRECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING THE CYSTOSCOPY, IMMEDIATELY FOLLOWING A PELVIC FLOOR REPAIR PROCEDURE PERFORMED USING AN UPHOLD VAGINAL SUPPORT SYSTEM, BLOOD WAS DISCOVERED IN THE PATIENT'S URINE. UPON FURTHER INVESTIGATION, THE PHYSICIAN DETERMINED THAT THE PATIENT'S URINARY BLADDER WAS PUNCTURED DURING THE DISSECTION PORTION OF THE INITIAL PROCEDURE. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE PERFORATION. A SEPARATE UROLOGIST REPAIRED THE PERFORATION IN THE PATIENT'S BLADDER AND PLACED A FOLEY CATHETER. THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN AMOUNT OF TIME BUT IS REPORTEDLY AT HOME NOW. NO FURTHER INFORMATION REGARDING THE PATIENT HAS BEEN FORTHCOMING. 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 DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE PERFORMED USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PATIENT'S URINARY BLADDER WAS PUNCTURED. THE COMPLAINANT INDICATED THAT THE PHYSICIAN IS UNSURE WHAT DEVICE CAUSED THE PERFORATION. A UROLOGIST REPAIRED THE PERFORATION IN THE PATIENT'S BLADDER AND PLACED A FOLEY CATHETER, WHICH REPORTEDLY WILL REMAIN INSIDE THE PATIENT FOR 1 WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R