BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3133854 · Received May 24, 2013

    Report

    Report Number
    3004170064-2013-00088
    Event Type
    Other
    Date Received
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    TEI BIOSSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE COMPLAINT ORIGINATED FROM AN ATTORNEY. IT IS NOT KNOWN WHAT THE PT WAS ORIGINALLY TREATED FOR. THE PRODUCT WAS IMPLANTED ON (B)(6) 2010. BOSTON SCIENTIFIC'S OBTRYX DEVICE ALSO IMPLANTED AT THIS TIME. ANOTHER XENFORM DEVICE WAS IMPLANTED ON (B)(6) 2012. BOSTON SCIENTIFIC'S PINNACLE DEVICE WAS ALSO IMPLANTED AT THIS TIME. THE COMPLAINT VIA THE ATTORNEY WAS THAT THE PT SUFFERED AN INJURY (UNSPECIFIED). IT IS NOT KNOWN WHEN THE VENT OCCURRED. IT IS NOT KNOWN IF THE EVENT IS RELATED TO THE FIRST OR THE SECOND IMPLANTED DEVICE OR TO BOTH. IT IS NOT KNOWN WHAT THE PT'S CURRENT. CONDITION IS. NO INFORMATION HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231460 XENFORM SURGICLA MESH FTM TEI BIOSSCIENCES INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other