BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21241910 · Received January 27, 2025

    Report

    Report Number
    9617229-2025-01458
    Event Type
    Injury
    Date Received
    January 27, 2025
    Report Date
    January 27, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION D4: SINCE THE AFFECTED SIDE IS UNKNOWN, ONLY CATALOG# WAS CAPTURED IN D4. FOLLOWING IS THE DEVICE INFORMATION FOR BOTH SIDES: SERIAL NUMBER (B)(6), LOT NUMBER 2192996 AND CATALOG NUMBER C-MHP-260. SERIAL NUMBER (B)(6), LOT NUMBER 2351420 AND CATALOG NUMBER C-MHP-260. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENTS OF LYMPHOMA-ALCL-SUSPECTED AND CAPSULAR CONTRACTURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: LYMPHOMA-ALCL SUSPECTED (HISTOPATHOLOGICAL MARKERS NOT PROVIDED), CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND PAIN.

    Description of Event or Problem · 0

    PATIENT REPORTED "WITH CONSTANT PAIN IN THE BREAST, CONTRACTURE", CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "POSSIBLE ANAPLASTIC LYMPHOMA WERE VERIFIED". HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE NOT BEEN RECEIVED. THIS FOR AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507644 CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L