BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT (LEFT)

    MDR report key: 25014708 · Received April 27, 2026

    Report

    Report Number
    MW5187318
    Event Type
    Injury
    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 "OTHER IMPLANT RUPTURED" FOR A NON-(B)(6) DEVICE. THIS RECORD IS FOR THE LEFT 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 MW5187319.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055093 BREAST IMPLANT (LEFT) PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown