BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3182066 · Received June 17, 2013

    Report

    Report Number
    3004170064-2013-00126
    Event Type
    Other
    Date Received
    June 17, 2013
    Report Date
    June 10, 2013
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR THIS LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER.

    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. ONE DEVICE WAS IMPLANTED ON (B)(6) 2007. BOSTON SCIENTIFIC'S OBTRYX DEVICE WAS ALSO IMPLANTED ON THIS DATE. A SECOND XENFORM DEVICE WAS IMPLANTED ON (B)(6) 2010. BOSTON SCIENTIFIC'S OBTRYX DEVICE WAS ALSO IMPLANTED ON THIS DATE. AMERICAN MEDICAL SYSTEM'S MINIARC DEVICE WAS ALSO IMPLANTED ON THIS DATE. 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 INFORMATION HAS BEEN CONFIRMED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273077 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-247 0704031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other