BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20076064 · Received August 27, 2024

    Report

    Report Number
    9617229-2024-19653
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 27, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF SEROMA WAS REVIEWED ON (B)(6), 2024. IT IS POSSIBLE TO DETERMINE THE LOT NUMBER 3113685 AND CATALOG NUMBER 115-290 OF THE PHOTOS PROVIDED. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: SEROMA: UNABLE TO OBSERVE. NO ADDITIONAL OBSERVATIONS WERE CARRIED OUT. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    CONTINUED E1: PHONE NUMBER: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF SEROMA 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: "LITTLE FLUID AROUND IMPLANT".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LITTLE FLUID AROUND IMPLANT". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE "LITTLE FLUID AROUND IMPLANT". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219642 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3113685

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention