BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 168 SALINE FILLED BREAST IMPLANT

    MDR report key: 15705713 · Received November 1, 2022

    Report

    Report Number
    9617229-2022-19213
    Event Type
    Injury
    Date Received
    November 1, 2022
    Report Date
    January 13, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENTS OF "BIOPSY ISN¿T HEALING," "FLUID SURROUNDING THE IMPLANT," "LYMPH GLANDS IN BREAST AND IN ARMPIT ARE SWOLLEN¿ ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: "BIOPSY ISN¿T HEALING," "FLUID SURROUNDING THE IMPLANT," "LYMPH GLANDS IN BREAST AND IN ARMPIT ARE SWOLLEN.¿

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, D6B, H6.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ANXIETY¿PRODUCT/PROCEDURE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. SEROMA: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. BLEEDING: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. PAIN: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. DELAYED HEALING: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. LYMPHADENOPATHY: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: ONE OPENING ON ANTERIOR SIDE ASSESSED AS SURGICAL DAMAGE. CREASE FOLD IS OBSERVED. RED PARTICLES ON THE SHELL ARE OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED UNKNOWN SIDE "HAD SYMPTOMS OF THE CANCER", "FLUID SURROUNDING THE IMPLANT THE HOLE WILL NOT CLOSE UP", "BREAST HAD BEEN LEAKING FLUID AND BLOOD THE ENTIRE TIME", "SWOLLEN A CUP SIZE BIGGER¿, ¿IS VERY PAINFUL¿, ¿ LYMPH GLANDS IN BREAST AND IN ARMPIT ARE SWOLLEN¿, AND ¿BIOPSY ISN¿T HEALING¿. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED UNKNOWN SIDE "HAD SYMPTOMS OF THE CANCER", "FLUID SURROUNDING THE IMPLANT THE HOLE WILL NOT CLOSE UP", "BREAST HAD BEEN LEAKING FLUID AND BLOOD THE ENTIRE TIME", "SWOLLEN A CUP SIZE BIGGER¿, ¿IS VERY PAINFUL¿, ¿ LYMPH GLANDS IN BREAST AND THE IN ARMPIT ARE SWOLLEN¿, AND ¿BIOPSY ISN¿T HEALING¿. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED UNKNOWN SIDE "HAD SYMPTOMS OF THE CANCER", "FLUID SURROUNDING THE IMPLANT THE HOLE WILL NOT CLOSE UP", "BREAST HAD BEEN LEAKING FLUID AND BLOOD THE ENTIRE TIME", "SWOLLEN A CUP SIZE BIGGER¿, ¿IS VERY PAINFUL¿, ¿ LYMPH GLANDS IN BREAST AND THE IN ARMPIT ARE SWOLLEN¿, AND ¿BIOPSY ISN¿T HEALING¿. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438015 STYLE 168 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2-503339

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention