BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8842700 · Received July 30, 2019

    Report

    Report Number
    9617229-2019-09298
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    August 25, 2012
    Report Date
    November 8, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CREASES FOLD, WEAR ABRASION AND OPENING(CURVED) ON ANTERIOR LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED AN OPENING CREASE(SHARP) ON ANTERIOR. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS AN OPENING CREASE(SHARP) ON ANTERIOR DUE TO FOLD(FLAW) OPENING.

    Description of Event or Problem · 0

    HEALTH PROFESSIONAL ADDITIONALLY REPORTED "MULTIPLE AREAS OF FLAT LINEAR CALCIFICATION". DEVICE WAS EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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. THE REASON FOR REOPERATION ARE DEFLATION AND CAPSULAR CONTRACTURE, BAKER GRADE III. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT REPORTED THE LEFT SIDE BREASTS FELT ¿FIRM AND LOOKED ABNORMAL DUE TO CAPSULAR CONTRACTURE¿ BAKER GRADE III. HEALTHCARE PROFESSIONAL REPORTED A DEFLATION AND "A LOT OF GLANDULAR TISSUE". DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637549 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1524392

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention