BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3230429 · Received July 16, 2013

    Report

    Report Number
    3005099803-2013-05848
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 #3005099803-2013-05911 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A N UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327946 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SOLYX SINGLE INCISION SLING SYSTEM