BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENFORM

    MDR report key: 2630802 · Received June 22, 2012

    Report

    Report Number
    3004170064-2012-00011
    Event Type
    Injury
    Date Received
    June 22, 2012
    Report Date
    June 21, 2012
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTL
    PMA / PMN Number
    K060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INFO INCLUDING LOT NUMBER WERE NOT AVAILABLE, THEREFORE, NO DEVICE HISTORY RECORD COULD BE REVIEWED. NO ADD¿L INFO HAS BEEN MADE AVAILABLE. THIS MAY BE A LEGAL CASE.

    Description of Event or Problem · 1

    THE ONLY INFO AVAILABLE ON THIS PT CAME FROM THE PT, NOT A HEALTH PROFESSIONAL. THE PT COMPLAINED OF UNSPECIFIED SERIOUS INJURY. IT IS PRESUMED THAT THE PT WAS TREATED WITH THE DEVICE, XENFORM, BUT THIS HAS NOT BEEN CONFIRMED BY A HEALTHCARE PROFESSIONAL AS WELL AS THE INITIAL DATE OF TREATMENT. IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THE PT HAS HAD AFTER THE PRESUMPTIVE TREATMENT WITH XENFORM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK