BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 291494 · Received July 25, 2000

    Report

    Report Number
    MW1019693
    Event Type
    Injury
    Date Received
    July 25, 2000
    Date of Event
    August 21, 1992
    Report Date
    June 13, 2000
    Manufacturer
    SURGITEK
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "S/P L MRM FOR QUESTIONABLE INTRADUCTAL VS LOBULAR CA. TOLD HIGH CHANCE OF BILATERALITY AND HAD MIRROR IMAGE BX R - WITH 0/19 LN'S + NED, UNDERWENT L BREAST RECONSTRUCTION WITH STAGED TISSUE EXPANSION WITH 550CC REPLICON. PT HAD H/O DELAY OF 2ND STAGE SECONDARY RASH ON LEFT BREAST. RX'D WITH HYDROCORTISONE BY DERMATOLOGIST. THIS CLEARED AND SX WAS APPARENTLY UNEVENTFUL. 1 MON AGO DEVELOPED BOTH THE RECURRENT RASH AND A TENSE, PURPLE, TENDER AREA IN THE MEDIAL L BREAST - WAS RX'D BOTH WITH ORAL CORTISONE AND CIPRO AND SX'S HAVE DECREASED. C/O SLOWER PROGRESSIVE FIRMNESS AND TENDERNESS IN L BREAST, INCREASED AND SYSTEMIC C/O'S DEVELOPING SINCE SX TO INCLUDE CHRONIC FATIGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK REPLICON 550CC FTR SURGITEK SIZE: 14 9360223

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| S