BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANTS

    MDR report key: 21468576 · Received February 26, 2025

    Report

    Report Number
    MW5166825
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    January 1, 2022
    Report Date
    February 22, 2025
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NEUROSURGEON WITH POST MASTECTOMY IMPLANTS. TWO YRS PLUS OF UNEXPLAINED MEDICAL PROBLEMS INCLUDING AUTOIMMUNE. I HAVE A RUPTURED IMPLANT AND AM SCHEDULED FOR EXPLANT IN MARCH. I WANT TO ADD TO THE DATA BASE OF WOMEN WITH BII. REF REPORT: MW5166826.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248857 SILICONE BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Disability MULTI-VITAMIN INJECTION| PROTONIX | RINVOQ | ZYRTEC