BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10762787 · Received October 30, 2020

    Report

    Report Number
    9617229-2020-18501
    Event Type
    Injury
    Date Received
    October 30, 2020
    Report Date
    October 30, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED " CAPSULAR FIBROSIS DIAGNOSED LOCALLY WITH SEVERE PERMANENT PAIN IN BOTH BREASTS... BAKER III ON RIGHT". THE FOLLOWING EVENTS ARE DEEMED NOT RELATED TO THE DEVICE:"SYSTEMATIC WITH WHOLE-BODY PAIN, EXHAUSTION, MUSCLE PAIN, BRAIN FOG, MUSCLE CRAMPS, CONCENTRATION DISORDERS, FORGETFULNESS, SWEATING, BREATHING DIFFICULTIES, PERMANENT FATIGUE REINFECTION EBV AND AGAIN WHISTLING GLANDULAR FEVER, SLEEP DISORDERS, ME/CFS UNTIL TODAY. NEW ALLERGIES SUCH AS RELAPSING DISHYDROSIS ECZEMA ON BOTH HANDS, FOOD INTOLERANCE AND DENTISTRY. MATERIALS (PZR TRIGGERS NEW ALLERGIES), CONJUNCTIVITIS, CHRONIC SINUSITIS, PERMANENT SINUSITIS, PERMANENTLY INCREASED EOSINOPHILS, INCREASED INFLAMMATION MARKERS, INCIPIENT TINNITUS, NIGHT SWEATS, DISCOMFORTS/TINGLING HANDS AND FEET, PALPITATIONS, NIGHT SWEATS, SHOULDER GIRDLE PAIN, CELL ACTIVATION, BLOOD VALUES IGE, CRP, EOS (AS WELL AS CD19, IL2) INCREASED. PERSISTENT FLU FEELING, SUBFEBRILE TEMPERATURES, CHILLS, BODY ACHES, HAIR LOSS, NEW HEADACHES, NOTICEABLY ALTERED LIVER IN SONOGRAPHY, JOINT PAIN, POLYNEUROPATHIES/SENSORY DISORDERS IN EXTREMITIES, NECK-SHOULDER-ARM SYNDROME, SUDDENLY HAY FEVER - ALLERGIC RHINITIS (ACUTE), SINCE THEN FREQUENT SNEEZING ATTACKS AND NASAL CONGESTION, CHRONIC SINUS INFECTIONS, DRY FLAKY SKIN ALL OVER THE BODY, HEART STUMBLING, WORD-FINDING DISORDERS". THIS RECORD RELATES TO RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228296 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention