BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCEND PC

    MDR report key: 2020244 · Received March 10, 2011

    Report

    Report Number
    3003990090-2011-00006
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CALDERA MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K083722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ASCEND PC MESH WAS IMPLANTED ON (B)(6), 2010. ON (B)(6), 2011, THE PATIENT PRESENTED WITH A SMALL EROSION AT THE SUTURE JUNCTION. A SMALL PIECE OF MESH WAS REMOVED. PATIENT IS ON A HIGH DOSE OF STEROIDS. PATIENT WAS GIVEN PREMARIN CREAM. AS OF (B)(6), 2011, THE PATIENT RESPONDED WELL TO THE PREMARIN CREAM AND IS DOING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCEND PC MESH SLING IMPLANT FTL CALDERA MEDICAL CAL-PC01 21853

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other