BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 23844847 · Received December 18, 2025

    Report

    Report Number
    3012883202-2025-01649
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 7, 2024
    Report Date
    May 26, 2026
    Manufacturer
    ESTABLISHMENT LABS S.A.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR COMPLAINT: DEVICE RUPTURE

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS ISSUED TO CORRECT A TYPOGRAPHICAL ERROR IN THE SERIAL NUMBER REPORTED IN THE I N I T I A L NOTIFICATION. INITIALLY REPORTED "(B)(6)", CORRECT SERIAL NUMBER FORMAT "(B)(6).

    Description of Event or Problem · 0

    MÉXICO. ALLEGEDLY, THE PATIENT PRESENTED WITH PAIN IN THE RIGHT BREAST, AND IMAGING STUDIES CONFIRMED RUPTURE OF THE RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289679 MOTIVA IMPLANTS SILKSURFACE FTR ESTABLISHMENT LABS S.A. RSF 295+Q 19121299

    Patients

    Seq Age Sex Outcome Treatment
    1