BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17139638 · Received June 15, 2023

    Report

    Report Number
    9617229-2023-09859
    Event Type
    Injury
    Date Received
    June 15, 2023
    Report Date
    September 12, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANATORY NOTE TO D.9: THE PREVIOUSLY SUBMITTED REPORT INDICATED, IN ERROR, THAT THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVENT OF CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.

    Additional Manufacturer Narrative · 0

    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. DEVICE PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. ¿ PATCH LOT NUMBER 1832037. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    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: RUPTURE.

    Description of Event or Problem · 0

    PATIENT REPORTED A LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED A LEFT SIDE RUPTURE VIA MRI. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED A LEFT SIDE RUPTURE VIA MRI. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049013 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1832037
    814628 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1832037

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention