BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8906014 · Received August 19, 2019

    Report

    Report Number
    9617229-2019-10753
    Event Type
    Injury
    Date Received
    August 19, 2019
    Report Date
    January 6, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.10 , G.7 , H.2 , H.3 , H.6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE AND GEL BLEED WAS RECEIVED ON NOVEMBER 26, 2019 WITH LOT NUMBER 172677. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: DEFORMATION, BROWN PARTICLES, WEAR ABRASION AND CREASES. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE WAS WITHIN SPECIFICATION. CLOUDY AND VOIDS AFTER AUTOCLAVE DISINFECTION PROCESS IN THE GEL. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING.

    Description of Event or Problem · 0

    REGULATORY AGENCY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND PERSPIRATION OF SILICON GEL THROUGH THE ENVELOPE. THE DEVICE HAS BEEN EXPLANTED.

    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: CAPSULAR CONTRACTURE BAKER GRADE III AND GEL BLEED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    REGULATORY AGENCY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND PERSPIRATION OF SILICON GEL THROUGH THE ENVELOPE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699913 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 172677

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention