BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN BIOCELL TEXTURED IMPLANT

    MDR report key: 8767687 · Received July 5, 2019

    Report

    Report Number
    MW5087899
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 2, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH H/O OF BREAST CA, UNDERWENT RECONSTRUCTION WITH SALT LOSS TEXTURED IMPATIENT. BREAST IMPLANT ASSOCIATED ALCL, FROM SALT-LOSS TEXTURED IMPLANT. ATYPICAL LYMPHOID CELLS, CD30+. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558895 ALLERGAN BIOCELL TEXTURED IMPLANT PROSTHESIS, IMPLANT, INFLATABLE, INTERNAL SALINE FWM ALLERGAN
    558896 ALLERGAN BIOCELL TEXTURED IMPLANT PROSTHESIS, IMPLANT, INFLATABLE, INTERNAL SALINE FWM ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| O| R