BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8695246 · Received June 13, 2019

    Report

    Report Number
    9617229-2019-06503
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    March 14, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 4/22/2019. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: "THE DEVICE RELATED TO THE REPORTED EVENT OF BROKEN DEVICE WAS RECEIVED ON MAY 02, 2019 WITH LOT NUMBER 3261404. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, DEFORMATION, BROWN PARTICLES. CLOUDY AND BUBBLES WERE OBSERVED AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS. NO OPENINGS OR ISSUES RELATED TO BROKEN DEVICE WERE OBSERVED." 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "BUBBLE INSIDE" AND "DETECTED ANTISEPTIC UNDER THE SHELL OF IMPLANT, WHICH TESTIFIES ITS COMPROMISED INTEGRITY." THIS DEVICE WAS INSERTED AND THEN IMMEDIATELY REMOVED. SURGERY COMPLETED WITH A BACK-UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489128 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3261404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention