BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLODERM (ACELLULAR HUMAN SKIN GRAFT)

    MDR report key: 2460643 · Received February 16, 2012

    Report

    Report Number
    1000306051-2011-00115
    Event Type
    Other
    Date Received
    February 16, 2012
    Date of Event
    January 1, 2011
    Report Date
    December 5, 2011
    Manufacturer
    NA
    Product Code
    GXQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO LACK OF INFO AVAILABLE, INCLUDING ALLODERM LOT NUMBER, THIS EVENT IS BEING REPORTED TO FDA TO COMPLY WITH THE 15-DAY REPORTING REQUIREMENT. LIFECELL WILL SUBMIT A F/U REPORT IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL THAT TWO PTS WHO UNDERWENT BREAST RECONSTRUCTION WITH EXPANDER, BY THE SAME PHYSICIAN IN THE LAST YEAR DEVELOPED INFECTIONS WHICH CULTURED FOR MYCOBACTERIUM FORTUITUM. THIS IS THE SECOND OF TWO REPORTS. LIFECELL IS IN THE PROCESS OF ATTEMPTING TO OBTAIN FURTHER INFO, INCLUDING LOT NUMBERS. REFER TO 1000306051-2011-00114 FOR REPORT FOR THE OTHER PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLODERM (ACELLULAR HUMAN SKIN GRAFT) NA GXQ NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention