BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16474352 · Received March 2, 2023

    Report

    Report Number
    9617229-2023-03853
    Event Type
    Injury
    Date Received
    March 2, 2023
    Report Date
    March 2, 2023
    Product Code
    FTR
    UDI-DI
    05060191601047
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT- IMPACT CODE: F2201. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF GRANULOMA 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: GRANULOMA . DEVICE EVALUATION:VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: VARIED INJURIES-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. PAIN: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. CAPSULAR CONTRACTURE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. EDEMA-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. LYMPHADENOPATHY-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. BLEEDING-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. INFECTION (UNKNOW ONSET)-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. DEPRESSION-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. SKIN RASH/DERMATITIS: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. GRANULOMA: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. MALAISE-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. HEADACHE-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. MYALGIA-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. DIZZINESS-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. OTHER MEDICAL-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED.

    Description of Event or Problem · 0

    PATIENT'S REPRESENTATIVE HAS REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE II", "BREAST PAIN", "SKIN RASH", "CAPSULE TISSUE (RIGHT AND LEFT, CLINICAL SPECIFICATION) WITH MODERATE FIBROSIS, SIGNS OF A HISTIOCYTIC REACTION AND, IN EACH CASE, SECTIONS WITH EMPTY CAVITIES DETECTED BY OPTIMETRY THAT CORRESPOND TO INDIVIDUAL SILICONOMAS". DEVICE HAS BEEN EXPLANTED. THE FOLLOWING EVENTS ARE NOT DEVICE RELATED; "FATIGUE","EXHAUSTION", "HEADACHE", "MIGRAINES", "PAIN IN THE NECK, SHOULDERS AND JOINT", "STOMUCH ACHE", "PAIN IN THE MUSCLES", "DIZZINESS", "ANXIETY WITH PANIC ATTACKS", "SLEEP DISORDER", "PSORIASIS", "DIFFICULTY CONCENTRATING", "¿HEART RACING", "HAIR LOSS", "LIMITED LIBIDO", "SEVERE WEIGHT GAIN" ,"SEVERE BODY ODOR", "PALE SKIN", "EYE BAGS", "FOOD INTOLERANCE", "HORMONAL PROBLEMS (MENOPAUSE AT 44)", "NIGHT SWEATS", "DEPRESSION", "CHRONIC MOUTH INFECTIONS", "STRONG GUM BLEEDING" ," FREQUENTLY SWOLLEN LYMPH NODES IN THE JAW AND NECK AREAS" ,"SWOLLEN FACE, HANDS, LEGS AND FEET".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503946 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR 2087046 05060191601047

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention