BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT BREAST IMPLANT BIOCELL SALINE

    MDR report key: 22814618 · Received August 15, 2025

    Report

    Report Number
    MW5174595
    Event Type
    Injury
    Date Received
    August 15, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ALLERGAN SALES, LLC.
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER COMPLAINS ABOUT ADVERSE EVENTS TO HER LEFT AND RIGHT BREAST IMPLANTS. HER LEFT IMPLANT HAS FORMED A CLASS FOUR CAPSULAR CONTRACTURE. HER SURGEON BELIEVES THE RIGHT SIDE HAS RUPTURED AS WELL BUT HAS A SCHEDULED APPOINTMENT FOR FURTHER INVESTIGATION. THIS DEVICE HAS BEEN ISSUED A RECALL IN 2019. REPORTER COMPLAINS ABOUT SEVERE BREAST AND LIMB DISCOMFORT. SHE WILL HAVE SURGERY ON (B)(6) 2025 TO EXTRACT BOTH LEFT AND RIGHT BREAST IMPLANTS. PT CODES: 4504, 2330, 1761. DEVICE CODE: 2682. REF REPORT: MW5174596.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726784 LEFT BREAST IMPLANT BIOCELL SALINE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN SALES, LLC. 168 27-168271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other