BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA SLING

    MDR report key: 2871583 · Received December 7, 2012

    Report

    Report Number
    3003990090-2012-00169
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 4, 2008
    Report Date
    November 6, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REPORTED BY ATTORNEY. PLAINTIFF CLAIMS TO HAVE DESARA SLING IMPLANTED ON (B)(6) 2008 AT (B)(6) MEDICAL CENTER IN (B)(6). THEREAFTER, PLAINTIFF EXPERIENCED MANY MEDICAL COMPLICATIONS DUE TO THE PRODUCT. THESE INCLUDED WITHOUT LIMITATION, URINARY INCONTINENCE, PAIN AND OTHER ADVERSE EFFECTS. AS DIRECT AND PROXIMATE RESULTS OF THE DEFECTS IN THE PRODUCT, PLAINTIFF EXPERIENCED PAIN AND SUFFERING, EMOTIONAL DISTRESS AND INCONVENIENCE. SHE HAS BEEN COMPELLED TO UNDERGO ONGOING MEDICAL CARE, INCLUDING ADDITIONAL SURGICAL PROCEDURES. PRODUCT WAS NOT RETURNED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA SLING SURGICAL MESH FTL CALDERA MEDICAL, INC. DESARA SLING 30000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other