BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT (RIGHT)

    MDR report key: 24480761 · Received March 2, 2026

    Report

    Report Number
    MW5184531
    Event Type
    Injury
    Date Received
    March 2, 2026
    Report Date
    February 24, 2026
    Manufacturer
    UNK
    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 A "RUPTURE/DEFLATION". LATER CONTACTED BACK CONFIRMING THIS EVENT PERTAINS TO A NON-(B)(6) DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. 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
    553054 BREAST IMPLANT (RIGHT) PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown