BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCEND

    MDR report key: 2871609 · Received December 7, 2012

    Report

    Report Number
    3003990090-2012-00204
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    September 20, 2010
    Report Date
    November 30, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT REPORTED BY ATTORNEY. THE LEGAL COMPLAINT STATES THAT PT CLAIMS TO HAVE SUFFERED BODILY INJURIES. INJURIES/SYMPTOMS INCLUDE RECURRENCE OF STRESS URINARY INCONTINENCE, CHRONIC VAGINAL PAIN, AND INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCEND SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-AC02 001037B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other