BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE

    MDR report key: 5917307 · Received August 28, 2016

    Report

    Report Number
    MW5064450
    Event Type
    Injury
    Date Received
    August 28, 2016
    Date of Event
    March 9, 2016
    Report Date
    August 28, 2016
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER FAT GRAFT TRANSFER TO MY BREAST, AN 8X8 PIECE OF STRATTICE WAS CUT AND LAYERED IN MY BREAST AFTER THE SURGEON MADE AN INCISION ABOVE THE PARI AREOLA. SURGERY WAS (B)(6) 2014. BLEEDING STARTED IN (B)(6) 2016 (18 MONTHS AFTER THE SURGERY). WAS MY DR DOING AN OFF LABEL PROCEDURE? NO ONE DOES THIS PROCEDURE OR KNOWS ANYTHING ABOUT IT. NO LITERATURE ON IT ANYWHERE. DR WALD, MY SURGEON, IS STUNNED AND DOESN'T KNOW WHAT TO DO. HE SAID HE CONSULTED WITH LIFECELL. LIFECELL SAID IT IS NOT THE STRATTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561294 STRATTICE STRATTICE FTM LIFECELL CORPORATION SP100051-474

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other