BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 2891235 · Received December 6, 2012

    Report

    Report Number
    3004170064-2012-00057
    Event Type
    Other
    Date Received
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    TEI BIOSCIENCES 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 SOLYX 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 EVENT OCCURRED. IT IS NOT KNOWN WHAT THE PT'S CURRENT CONDITION IS. NO INFO HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other