BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8627606 · Received May 21, 2019

    Report

    Report Number
    9617229-2019-04376
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    July 7, 2011
    Report Date
    May 21, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS RECORD WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 24/OCT/2010, 23/JAN/2013, 23/APR/2013, 25/APR/2014, AND 22/APR/2019. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. THE EVENTS OF INFECTION, PAIN, AND NIPPLE DISCHARGE ARE PHYSIOLOGICAL COMPLICATIONS; ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. REASON FOR REOPERATION LEFT BREAST MODERATE PAIN, LEFT BREAST INFECTION, NIPPLE DISCHARGE, LEFT SIDE LUMP AT THE "TOP OF THE BREAST AND IT LOOKS LARGER THAN IT ONCE DID". THIS REPORT IS SUBMITTED BEYOND 30-CALENDAR DAYS FROM ALLERGAN¿S RECEIPT DUE TO THE EXEMPTION TRANSITION PERIOD.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT BREAST MODERATE PAIN. THERE IS NO INDICATION OF TREATMENT, DEVICE REMAINS IMPLANTED. PATIENT REPORTED HAVING BEEN TREATED FOR A LEFT BREAST INFECTION. PATIENT REPORTED HAVING NIPPLE DISCHARGE (FLUID) (SIDE IS NOT SPECIFIED). PATIENT REPORTED ¿LEFT SIDE LUMP AT THE TOP OF THE BREAST¿ AND ¿LOOKS LARGER THAN IT ONCE DID¿. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422028 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1588068

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR