BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2880385 · Received December 19, 2012

    Report

    Report Number
    3005099803-2012-06163
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED PAIN DUE TO THE ERODED MESH AND ADDITIONAL MEDICAL TREATMENT. ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT REPORTED STRESS URINARY INCONTINENCE POST-PROCEDURE AND WAS GIVEN MEDICATION (TYPE OF MEDICATION UNSPECIFIED) TO TREAT THE INCONTINENCE. IN (B)(6) OF 2012, THE PATIENT COMPLAINED OF FEELING LIKE HER BLADDER HAD DROPPED. HOWEVER, UPON EXAMINATION BY THE PHYSICIAN, NO COMPLICATIONS OR EROSION WERE OBSERVED. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE STABLE. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention