BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 8685356 · Received June 10, 2019

    Report

    Report Number
    1645337-2019-13566
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 13, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005223
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: SEROMA/ALCL CONCOMITANT PRODUCTS: MENTOR MEMORYSHAPE BREAST IMPLANT 495CC, CATALOG NUMBER 3341302, SERIAL NUMBER: (B)(4), LOT NUMBER 6894131. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 495CC ON (B)(6) 2015 POST EXPANSION WITH ALLERGAN TISSUE EXPANDERS IMPLANTED FROM (B)(6) 2015 THROUGH (B)(6) 2015 DEVELOPED RIGHT BREAST SWELLING THAT WORSENED OVER THE COURSE OF THE 2 WEEKS BEFORE PRESENTING TO THE OFFICE ON (B)(6) 2019. IT IS COINCIDENTAL THAT SHE STARTED SOME PHYSICAL ACTIVITY WITH GOLFING ABOUT THE SAME TIME. SHE HAS NO OTHER SYMPTOMS. NO FEVER OR CHILLS OR REDNESS. THE PHYSICIAN NOTED A RATHER LARGE FLUID COLLECTION AROUND THE RIGHT SIDE. THE PHYSICIAN ASPIRATED FLUID AT THE MEDIAL PORTION OF THE RIGHT BREAST. THE FLUID WAS VERY VISCOUS THICK STICKY YELLOW LIQUID. IT IS SENT TO THE PATHOLOGIST FOR CULTURE AND CYTOLOGY. THE CYTOPATHOLOGY REPORT INDICATED THE DIAGNOSIS OF BIA-ALCL (CD30+, ALK-) ON (B)(6) 2019. THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH CAPSULECTOMIES WITHOUT REPLACEMENT ON (B)(6) 2019. THE PATIENT HAS NOT BEEN TREATED FOR HER ALCL THUS FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477901 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6890094 00081317005223

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention