BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE MEND 5X6

    MDR report key: 1884852 · Received October 15, 2010

    Report

    Report Number
    MW5017898
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 13, 2010
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DIAGNOSIS: MASSIVE TEAR OF RIGHT ROTATOR CUFF, THIS WAS SURGICALLY REPAIRED ON (B)(6) 2010, USING TEI BIOSCIENCES INC TISSUE MEND. TEN DAYS AFTER SURGERY, PT WAS NOTED TO HAVE BULGE AND SOME REDNESS. THE PT WAS PLACED ON ANTIBIOTICS WITH NO RESOLVE. ON (B)(6) 2010, THE PT WAS RETURNED TO SURGERY FOR I & D OF WOUND. DURING SURGERY, IT WAS NOTED THAT THE TISSUE MEND HAD TOTALLY DISINTEGRATED AND THE BACTERIA CULTURED FROM THE WOUND WAS VERY UNUSUAL. IT IS TSUKAMURELLA SP. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: TO REPAIR ROTATOR CUFF TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE MEND 5X6 GRAFT TISSUE MEND FTM TEI BIOSCIENCES INC. 6495-9-001 1006018

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| S