BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1834260 · Received September 14, 2010

    Report

    Report Number
    3005099803-2010-03807
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE (CRESCENT INCISION USED) PERFORMED ON (B)(6)2010, USING AN UPHOLD VAGINAL SUPPORT SYSTEM WAS COMPLETED SUCCESSFULLY WITHOUT ISSUES. DURING A FOLLOW-UP VISIT ON (B)(6)2010, THE PHYSICIAN DISCOVERED THE PATIENT'S INCISION HAD REOPENED AND A STRONG ODOR WAS PRESENT. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM TO REMOVE THE DEAD TISSUE SURROUNDING THE OPEN INCISION AND IRRIGATE THE WOUND. THE INCISION WAS LEFT OPEN TO HEAL NATURALLY. NO MESH EROSION WAS NOTED. THE PATIENT WAS PRESCRIBED PREMARIN ESTROGEN CREAM FOR THE TREATMENT OF THE OPEN WOUND AND WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. THE PHYSICIAN CURRENTLY HAS NO PLANS TO GO BACK INTO THE PATIENT OR PERFORM ADDITIONAL MEDICAL INTERVENTIONS BUT WILL CONTINUE TO MONITOR THE PATIENT. CURRENTLY, THE PATIENT IS REPORTEDLY "DOING WELL."

    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 56 YR Required Intervention