BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18156150 · Received November 16, 2023

    Report

    Report Number
    9617229-2023-18927
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    July 15, 2023
    Report Date
    December 12, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191600552
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F15. 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 INFECTION 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE AND INFECTION (LATE ONSET).

    Additional Manufacturer Narrative · 0

    THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. CLARIFICATION TO D9-DATE IS WHEN DEVICE PHOTO WAS RECEIVED. FURTHER INVESTIGATION. WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER 11541125 WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS RELATED TO THE REPORTED EVENT. PRIMARY PACKAGING INSPECTION WAS SUCCESSFULLY COMPLETED AND RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE, AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. THE STERILIZATION RUN 101945 IS NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH INFECTION WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO THE MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT, AND NO ER/ NCR(S) OR TEMPORARY CHANGES WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED TO THIS LOT AND THE COMPLAINT, NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. PHOTO ANALYSIS. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG NUMBER THROUGH THE PHOTOS PROVIDED. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. ¿ INFECTION (LATE ONSET): UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ CYST-NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ DOUBLE CAPSULE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ LUMP/NODULE-NDR UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTING, RUPTURE FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED IMAGING RESULTS " ULTRASOUND RESULT SHOW " INFECTION OF THE RIGHT PROSTHESIS, ASYMPTOMATIC, SIMPLE CYSTS, IN THE RIGHT BREAST SUBPECTORAL PROSTHESIS WITH IMAGES OF DOUBLE CAPSULE AND IMAGE COMPATIBLE WITH POSSIBLE RUPTURE OF PROSTHESIS, NODULE OF 13 X 6 MM COMPATIBLE WITH POSSIBLE FIBROADENOMA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322224 STYLE 120 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1114365 05060191600552

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention