BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 23014646 · Received September 10, 2025

    Report

    Report Number
    9617229-2025-15323
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    July 1, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF "CAPSULAR CONTRACTURE, BAKER GRADE IV" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE 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: CAPSULAR CONTRACTURE, BAKER GRADE IV, GEL FRACTURE, RUPTURE.

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H6 OF INITIAL: DISREGARD EVENT CODE A040101 FRACTURE AS THE EVENT IS NOT SERIOUS OR FDA REPORTABLE AND WILL BE UNREPORTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "IMPLANT HAS 3 OR 4 CRACKS", AND CAPSULAR CONTRACTURE, BAKER GRADE IV. PATIENT LATER REPORTED RUPTURE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT ADDITIONALLY REPORTED BIOCELL SURFACE WAS USED. HEALTHCARE PROFESSIONAL LATER REPORTED "SEVERE CONTRACTURE PAIN WITH RESTRICTION OF MOVEMENT IN THE ARM. RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500343 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention