BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 11462050 · Received March 10, 2021

    Report

    Report Number
    MW5099910
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    July 16, 2020
    Report Date
    March 6, 2021
    Manufacturer
    INAMED / MCGHAN / ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2020 I WAS DIAGNOSED WITH LYMPHOMA CAUSED BY MY BREAST IMPLANTS. SURGERY WAS DONE IN 2006: IMPLANTS INAMED MCGHAN, ST 110 240CC RIGHT ONE SN (B)(4), LOT 1253109, LEFT ONE SN (B)(4), LOT 1253106. THIS MAKE AND MODEL ARE IN THE DANGEROUS RECALL LIST OF ALLERGAN PRODUCTS. HISTOLOGICAL TESTS OF 3 REMOVED LYMPHATIC NODES WERE DONE (B)(6) 2020 AND WAS ALSO REVISED BY ANOTHER INSTITUTE (B)(6) 2020. ON (B)(6) 2021 SURGEON REMOVAL OF IMPLANTS PLANNED. AFTER REMOVAL CAPSULE WILL BE SENT FOR PATHOLOGY TEST. I WILL UPDATE YOU ABOUT TEST CONCLUSION. MY EMAIL: (B)(6) KIND REGARDS, (B)(6), MY BIRTH DAY (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346652 BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR INAMED / MCGHAN / ALLERGAN MODEL: ST 110 VOLUME 240CC 1253109
    346653 BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR INAMED / MCGHAN / ALLERGAN MODEL: ST 110 VOLUME 240CC 1253106

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| O| S