BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRIX XM

    MDR report key: 2867896 · Received December 7, 2012

    Report

    Report Number
    3003990090-2012-00179
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    July 1, 2009
    Report Date
    November 8, 2012
    Manufacturer
    SYNOVIS LIFE TECHNOLOGIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT REPORTED BY ATTORNEY. LEGAL COMPLAINT STATES THAT THE PATIENT EXPERIENCED COMPLICATIONS INCLUDING BUT NOT LIMITED TO PAIN, INFECTIONS, PAINFUL INTERCOURSE AND INCONTINENCE FROM THE DEFECTIVE MESH REQUIRING ADDITIONAL MEDICAL CARE AND TREATMENT AND ULTIMATELY SURGICAL INTERVENTION. PLAINTIFF CLAIMS TO HAVE CALDERA HYDRIX IMPLANTED ON (B)(6) 2009. NO LOT NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRIX XM SURGICAL MESH FTL SYNOVIS LIFE TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other