BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2842345 · Received November 21, 2012

    Report

    Report Number
    3005099803-2012-05482
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN UPHOLD VAGINAL SUPPORT SYSTEM ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, APPROXIMATELY 2 TO 3 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED A VARYING DEGREE OF BUTTOCK PAIN. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. ALL OTHER INFORMATION IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 Other