BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST IMPLANT

    MDR report key: 25149057 · Received May 12, 2026

    Report

    Report Number
    MW5188014
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Report Date
    May 4, 2026
    Manufacturer
    UNK
    Product Code
    FTR
    Product Problem
    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)). ALLEGED EVENT: HEALTHCARE PROFESSIONAL REPORTED "EXPLANTED DEVICES ARE TEXTURED" OF A NON-(B)(6) DEVICE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). PT: 4580. DEVICE: 3190. REF: MW5188015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75923 BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1