BEUDAMED
    FDA Adverse Event Other Summary report: N

    DESARA

    MDR report key: 1971917 · Received January 21, 2011

    Report

    Report Number
    3003990090-2011-00003
    Event Type
    Other
    Date Received
    January 21, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 21, 2011
    Manufacturer
    CALDERA MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K072456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DESARA MESH WAS IMPLANTED ON (B)(6), 2010. AT THE PATIENT'S 6 WEEK FOLLOW UP VISIT, THE SURGEON OBSERVED A MESH EROSION. THE SURGEON TRIMMED THE MESH AND PACKED WITH PREMARIN. CURRENTLY, PATIENT STILL HAS A SLIGHT EROSION BUT IT DOES NOT AFFECT HER EVERYDAY LIFE. SHE IS NOT SEXUALLY ACTIVE AND DOES NOT WANT TO DO ANYTHING FURTHER AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA MESH SLING IMPLANT FTL CALDERA MEDICAL CAL-DS01 007003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other