BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STYLE 133PLUS

    MDR report key: 12344645 · Received August 19, 2021

    Report

    Report Number
    9617229-2021-50232
    Event Type
    Injury
    Date Received
    August 19, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K143354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF "CELLULITIS, LYMPHADENOPATHY, INFECTION (UNKNOWN ONSET)" 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: CELLULITIS, LYMPHADENOPATHY, INFECTION (UNKNOWN ONSET), PAIN, DEPRESSION, EDEMA, ANXIETY-PRODUCT/PROCEDURE, HEMATOMA, SENSATION INCREASE/DECREASE, OTHER-MEDICAL-NDR, HEADACHE-NDR, INFECTION (UNKNOWN ONSET), INFECTION (UNKNOWN ONSET)-NDR, MALAISE-NDR, VARIED INJURIES-NDR, LUPUS-NDR, INFLAMMATION/IRRITATION-NDR.

    Description of Event or Problem · 1

    PATIENT REPRESENTATIVE REPORTED UNKNOWN SIDE ¿SWOLLEN AND TENDER LYMPH NODES IN UNDERARMS AND THROAT¿, ¿CELLULITIS¿, ¿INFECTION¿ AND "DEPRESSION", 'SWELLING" "ANXIETY", "HEMATOMA", "NUMBNESS AND TINGLING IN ARMS, ". ADDITIONALLY IT WAS ALSO REPORTED ¿CENTRAL SENSITIZATION SYNDROME WITH FIBROMYALGIA FEATURES, MEMORY ISSUES, REOCCURRING THRUSH, SEVERE HAIR LOSS, HUMMING IN EARS, DIFFICULTY CONCENTRATING, PANIC ATTACKS, AND MOOD SWINGS, NIGHT SWEATS, FATIGUE, PAIN AROUND THE IMPLANTS, MUSCLE DAMAGE BURNING SENSATIONS AND CONSTANT THROBBING NEAR IMPLANT SITE AND IN UNDERARMS, SWELLING AT IMPLANT SITE, INTENSE MIGRAINES, SEVERE UNEXPLAINED WEIGHT LOSS, DIAGNOSES OF BREAST IMPLANT ILLNESS, UNEXPLAINED BODY ODOR, RESPIRATORY ISSUES, RIGHT CHEST RIB CONCAVE WITH CHEST TIGHTNESS ON BOTH SIDES, COSTOCHONDRITIS, TIETZE SYNDROME, POSITIVE LUPUS SYMPTOMS, DRY EYES AND MOUTH, EXACERBATION OF EXISTING HEALTH CONDITIONS (THYROID) AND SEVERE EMOTIONAL DISTRESS"; THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240108 UNK STYLE 133PLUS EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention