BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 23617715 · Received November 21, 2025

    Report

    Report Number
    MW5179230
    Event Type
    Injury
    Date Received
    November 21, 2025
    Report Date
    October 16, 2025
    Manufacturer
    UNKNOWN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION 803.22, WE WISH TO INFORM YOU OF AN ADVERSE EVENT ASSOCIATED WITH ANOTHER MANUFACTURER'S DEVICE WHICH HAS BEEN RECEIVED AT ALLERGAN INC. ((B)(6) REF (B)(4). ALLEGED EVENT: HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" VIA MRI OF A NON-(B)(6) DEVICE. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED. THE DEVICE WILL BE RETURNED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490702 BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown