BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST PROSTHESIS

    MDR report key: 22556535 · Received July 21, 2025

    Report

    Report Number
    MW5173033
    Event Type
    Injury
    Date Received
    July 21, 2025
    Report Date
    July 16, 2025
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF AN ADVERSE EVENT, AS WE HAVE BECOME AWARE THAT THE SUSPECT DEVICE (PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE [FWM]) WAS NOT MANUFACTURED OR IMPORTED BY (B)(6) WORLDWIDE LLC. ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT INDICATES THAT THE DEVICE WAS MANUFACTURED BY ALLERGAN. IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A SMOOTH SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. NO EXPLANATION DATE WAS REPORTED AND THE DEVICE REMAINS IMPLANTED IN THE PATIENT. 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
    2725047 BREAST PROSTHESIS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown