BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8639869 · Received May 24, 2019

    Report

    Report Number
    9617229-2019-04807
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    March 6, 2019
    Report Date
    May 24, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED FLAT CREASES AND ONE EXTENDED OPENING. A WEIGHT TEST OF THE DEVICE WAS PERFORMED WHICH VERIFIED THE DEVICE WAS UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED ONE OPENING IN THE SHELL WITH A SHARP EDGE AND STRESS MARKS ASSESSED AS A SURGICAL IMPACT OPENING, WEAR ABRASION, AND STRESS MARKS. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFIED THE SHELL THICKNESS WITHIN THE SPECIFICATION. BASED ON THE DEVICE ANALYSIS, THE FINAL ASSESSMENT IS A SHARP EDGE OPENING IN THE SHELL WITH STRESS MARKS DUE TO A SURGICAL IMPACT OPENING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 IS RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III. THESE ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, "PAIN AND SHAPE CHANGE," AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, "PAIN AND SHAPE CHANGE," AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434074 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2475767

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention