BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA SLING

    MDR report key: 2871568 · Received December 7, 2012

    Report

    Report Number
    3003990090-2012-00176
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REPORTED BY ATTORNEY. DESARA PRODUCT HAS NOT BEEN IDENTIFIED IN THE DOCUMENTS PROVIDED, HOWEVER, AS A PRECAUTIONARY MEASURE, CALDERA MEDICAL IS FILING THIS REPORT. NO LOT NUMBERS WERE GIVEN. NO SPECIFIC CLAIMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA SLING CAL-DS01 FTL CALDERA MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other