BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8753316 · Received July 2, 2019

    Report

    Report Number
    9617229-2019-07692
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 2, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED SIDE OF THE DEFLATION IS UNKNOWN. THE LEFT SIDE SERIAL NUMBER IS (B)(4) WITH LOT NUMBER 1178708. THE RIGHT SIDE SERIAL NUMBER IS (B)(4) WITH LOT NUMBER 1140594. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION WAS REPORTED AS DEFLATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A DEFLATION. DEVICE REMAINS IMPLANTED. THE AFFECTED SIDE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548137 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention