BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE INSPIRA COHESIVE BREAST IMPLANTS

    MDR report key: 13975517 · Received April 1, 2022

    Report

    Report Number
    13975517
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 29, 2022
    Report Date
    March 30, 2022
    Manufacturer
    ALLERGAN, INC.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BILATERAL BREAST IMPLANT REMOVAL DUE TO RUPTURED IMPLANTS. PATHOLOGY REPORT: RIGHT BREAST REMOVAL 794G 12.0X 12.0X 7.5CM DIFFUSELY DISRUPTED IMPLANT WITH A DIFFUSELY DISRUPTED WALL. THE WALL DISPLAYS THE INSCRIPTION STYLE SCX LOT 3148049 ALLERGAN 800CC. LEFT BREAST REMOVAL 790G 12.0X 12.0 X 8.5 CM DIFFUSELY DISRUPTED IMPLANT. THE WALL IS DIFFUSELY DISRUPTED AND DISPLAYS THE INSCRIPTION STYLE SCX LOT 3110990 ALLERGAN 800CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2690041 NATRELLE INSPIRA COHESIVE BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN, INC. SCX-800 3148049, 3110990

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA Female