BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 9298892 · Received November 8, 2019

    Report

    Report Number
    9617229-2019-17386
    Event Type
    Injury
    Date Received
    November 8, 2019
    Report Date
    August 10, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION WAS PREVIOUSLY SUBMITTED IN DUPLICATE MEDWATCH 2019858 AND 2213789 AND IS BEING CONSOLIDATED INTO THIS REPORT.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE PAIN AND RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE REASON FOR REOPERATION IS RUPTURE. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENTS, PRODUCT, AND PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT SIDE PAIN AND RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089918 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention