BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREAST IMPLANT (RIGHT)

    MDR report key: 25014720 · Received April 27, 2026

    Report

    Report Number
    MW5187319
    Event Type
    Other
    Date Received
    April 27, 2026
    Report Date
    April 22, 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 "RUPTURE" OF A NON-(B)(6) DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. PATIENT CODE: 1924. DEVICE CODE: 1546. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5187318.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055094 BREAST IMPLANT (RIGHT) PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown