BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3163066 · Received June 11, 2013

    Report

    Report Number
    3005099803-2013-05113
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-05114 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE PATIENT, POST-OPERATIVELY, SHE CONTINUES TO EXPERIENCE URINARY TRACT INFECTIONS AND SOMETIMES KIDNEY INFECTIONS. AS A RESULT, SHE TAKES BACTRIM AND NITROFURANTOIN DAILY. SHE ALSO EXPERIENCES CHRONIC SEVERE PAIN (LOCATION UNKNOWN) AND DYSPAREUNIA. SHE TAKES PERCOCET AS NEEDED FOR THE PAIN, WHICH INCLUDES VERY EARLY EACH MORNING BECAUSE SHE AWAKENS FROM THE PAIN. THE PAIN IS WORSE UPON LYING DOWN. SHE ALSO TAKES VALIUM CREAM VAGINALLY FOR DYSPAREUNIA. REPORTEDLY, NEITHER HER GYNECOLOGIST NOR HER NEUROLOGIST HAS BEEN ABLE TO PINPOINT THE CAUSE OF THE PAIN. THE PATIENT PLANS ON CONSULTING WITH HER GYNECOLOGIST REGARDING POSSIBLE DEVICE REMOVAL. 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
    263731 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 0ML9062301

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention OBTRYX HALO SINGLE SYSTEM DEVICE