BEUDAMED
    FDA Adverse Event Other Summary report: N

    XENFORM

    MDR report key: 3205076 · Received June 28, 2013

    Report

    Report Number
    3004170064-2013-00133
    Event Type
    Other
    Date Received
    June 28, 2013
    Report Date
    June 27, 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

    TWO DEVICES WERE IMPLANTED DURING THE SAME PROCEDURE. THE FIRST DEVICE WAS LOT # 0802003, PN 830-247 WITH MFG DATE OF 02/2008 AND AN EXP DATE OF 10/31/2010. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER. THE SECOND DEVICE WAS LOT # 0803016, PN 30-243 WITH A MFG DATE OF 04/02/2008 AND AN EXP DATE OF 08/31/2010. THE DEVICE HISTORY RECORD 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. TWO DEVICES WERE IMPLANTED ON (B)(6) 2008. 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
    296016 XENFORM SURGICAL MESH FTM TEI BIOSCIENCES INC. 830-243, 830-247 0803016, 0802003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other