BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 24331668 · Received February 12, 2026

    Report

    Report Number
    MW5183742
    Event Type
    Injury
    Date Received
    February 12, 2026
    Report Date
    February 5, 2026
    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)). HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" OF A NON-(B)(6) DEVICE. PATIENT CODE: 1761; 1924. DEVICE CODE: 4001. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCING REPORT MW5183741.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390482 BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown