BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXTURED BREAST IMPLANT

    MDR report key: 8522638 · Received April 16, 2019

    Report

    Report Number
    MW5085909
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    February 6, 2019
    Report Date
    April 14, 2019
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BILATERAL ALCL. DO YOU HAVE A PICTURE OF THE PRODUCT? YES. PLACED >20 YEARS AGO. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310415 TEXTURED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNK
    310416 TEXTURED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening