BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2955220 · Received February 11, 2013

    Report

    Report Number
    3005099803-2013-00843
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES IMPLANTED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2013-00845 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN DUE TO ERODED MESH AND ADDITIONAL MEDICAL TREATMENT. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS LAST SEEN ON (B)(6) 2011. AT THIS TIME, THE PATIENT STATED THAT SHE WAS "FEELING BETTER BUT NOT COMPLETELY BACK TO NORMAL." ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58290 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0070603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ADVANTAGE FIT SYSTEM