BEUDAMED
    FDA Adverse Event Summary report: N

    FLEX HD, HUMAN ALLOGRAFT

    MDR report key: 1570668 · Received January 6, 2010

    Report

    Report Number
    3001236616-2009-00050
    Date Received
    January 6, 2010
    Date of Event
    June 25, 2009
    Report Date
    December 15, 2009
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS RECEIVED ON DECEMBER 4, 2009, AND WITH THIS, THE INVESTIGATION COULD BEGIN.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A (B)(6) FEMALE WITH A HISTORY OF UNDERGOING CHEMOTHERAPY HAD RIGHT BREAST RECONSTRUCTION WITH A TISSUE EXPANDER AND DERMAL GRAFT AND WAS RELEASED THE NEXT DAY. SHE HAD ONE PREVIOUS SURGERY AT THIS SITE. ON (B)(6) 2009, THE PT DEVELOP SIGNS OF AN INFECTION, WHICH ARE DESCRIBED AS "RED, SWOLLEN, AND FLUCTUANT." THERE WAS NO SIGN OF FEVER OR ELEVATED WHITE BLOOD CELLS. SHE WAS READMITTED TO THE HOSPITAL ON (B)(6) 2009, AND THE TREATMENT PRESCRIBED WAS TREATMENT WITH ANTIBIOTICS AND REMOVAL OF THE GRAFT AND TISSUE EXPANDER. ON (B)(6) 2009, WOUND SITE CULTURES WERE TAKEN AND GREW (B)(6). THE PT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2009, AND AS OF (B)(6) 2009, THE PT IS LISTED AS "IMPROVING." DOSE, FREQUENCY AND ROUTE USED: SINGLE USE, 64. THERAPY DATES: (B)(6) 2009; (B)(6) 2009. DIAGNOSIS FOR USE: SOFT TISSUE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX HD, HUMAN ALLOGRAFT NA LMO 00295079

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R TISSUE EXPANDER