BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 11258614 · Received February 1, 2021

    Report

    Report Number
    9617229-2021-00620
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    January 2, 2021
    Report Date
    April 18, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENTS OF LYMPHADENOPATHY AND INFECTION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE ADDIOTNALLY REPORTED PAIN, CHEST PAIN, ACHES-NDR, ITCHING-NDR, BACK PAIN, NECK PAIN-NDR, LYMPHADENECTOMY AND BREAST INFECTION, PUPURA-NDR, ARETHYMIA-NDR, SEVERE EMOTIONAL DISTRESS AND ANXIETY, FEAR OF BREAST CANCER, SICKNESS AND LOSS OF HOPE-NDR, AND CHILLS, IMBALANCE, NAUSEA, FREQUENT URINATION, KETONES, BLOOD IN URINE AND HIGH SUGAR-NDR.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE NOTED. 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: ¿DEFLATION, RASH, LUMP/NODULE, FEVER, THROWING UP, DIARRHEA¿.

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT SIDE DEFLATION, LUMP/ NODULE "BALL" UNDER RIGHT ARMPIT", AND SKIN RASH. PATIENT ADDITIONALLY REPORTED FEVER, THROWING UP, DIARRHEA, AND SUFFERED A PERSONAL INJURY; WHICH ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155694 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2169975

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention