BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15765163 · Received November 9, 2022

    Report

    Report Number
    9617229-2022-18314
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    March 16, 2011
    Report Date
    October 24, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 26/APR/2011, 29/JAN/2014, 23/OCT/2014, 23/JUL/2018. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: PAIN, IRRITATION/INFLAMMATION, LUMP AND SYMMASTIA.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE SEVERE PAIN, EXPERIENCING "UNUSUAL PAIN, TINGLING, SWELLING, NUMBNESS, OR BURNING OF THE BREAST," AND EXPERIENCING "HARD KNOTS OR LUMPS SURROUNDING THE IMPLANT OR IN THE ARMPIT." PATIENT ADDITIONALLY REPORTED "DOES NOT HAVE ANY CLEVEAGE AND IT LOOKS LIKE SHE HAS A UNIBOOB." NO TREATMENT PROVIDED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2954029 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1768416

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention