BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11446059 · Received March 9, 2021

    Report

    Report Number
    9617229-2020-21540
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    November 12, 2019
    Report Date
    March 9, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS IN RESPONSE TO FDA REPORT NUMBER 5092445. ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: VISUAL AND MICROSCOPIC ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: AROUND 0-25% OF THE SHELL IS MISSING, FOLD CREASES, WEAR ABRASION, STRESS MARKS, BROKEN SHELL WITH SMOOTH EDGE IN THE SAME LOCATION OF CREASE. WEIGHT TEST OF THE EXPLANTED MATERIAL WAS VERIFIED AND IT WAS UNDERWEIGHT. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS BROKEN SHELL WITH SMOOTH EDGE IN THE SAME LOCATION OF CREASE ASSESSED AS FOLD FLAW OPENING AND MISSING SHELL THAT IS ASSESSED AS INCONCLUSIVE. THE EVENT OF "SEROMA" 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: SEROMA-LATE AND RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. PATIENT REPORTED VIA REGULATORY AGENCY LEFT SIDE "RUPTURED", "NODULE", "LEAKING", "SEROMA" AND IRREGULAR SHAPE CAPSULE THAT CONTAINED BRIGHT YELLOW-GREEN SILICONE". PATIENT ALSO REPORTED "DECREASE IN VISION", "SWELLING", "JOINT PAIN", "CHRONIC FATIGUE", "HAIR LOSS", "MENTAL ANXIETY"; THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339743 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2267728

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention