BEUDAMED
    FDA Adverse Event Other Summary report: N

    DESARA

    MDR report key: 2001121 · Received February 17, 2011

    Report

    Report Number
    3003990090-2011-00005
    Event Type
    Other
    Date Received
    February 17, 2011
    Date of Event
    October 1, 2010
    Report Date
    February 9, 2011
    Manufacturer
    CALDERA MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K072456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DESARA MESH WAS IMPLANTED ON (B)(6), 2010. AT A FOLLOW UP VISIT, THE PATIENT MENTIONED THAT THE AREA WAS "TENDER TO THE TOUCH" AND REPORTED PAINFUL INTERCOURSE. IT WAS FOUND THAT THE AREA LATERAL TO THE URETHRA ON BOTH SIDES WAS "TENDER TO THE TOUCH". THE SURGEON SAID THAT HE CAN FEEL THE SLING HAS "CORDED UP" IN THOSE AREAS. DURING THE IMPLANTATION OF THE DEVICE, THE PATIENT DISPLAYED POOR TISSUE QUALITY AS SHE KEPT TEARING IN AREAS THAT THE SURGEON WASN'T EVEN WORKING ON. THE SURGEON HAD TO SUTURE UP THE PATIENT MULTIPLE TIMES DURING AND AFTER THE SURGERY. THE PATIENT IS GENERALLY HAPPY WITH THE PROCEDURE AND IS CONTINENT. THE PATIENT WAS LAST SEEN BY THE SURGEON ON (B)(6), 2011. THE SURGEON WILL CONTINUE TO FOLLOW UP ON THIS PATIENT. CALDERA MEDICAL HAS NOT RECEIVED ANY COMPLAINTS OF SLINGS "CORDING UP" OR CONTRACTING PRIOR TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA MESH SLING IMPLANT FTL CALDERA MEDICAL CAL-DS01 30011

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other