BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18862453 · Received March 7, 2024

    Report

    Report Number
    9617229-2024-03949
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG NUMBER THROUGH THE PHOTOS PROVIDED. DEVICE PATCH WITH LOT NUMBER 3170512 AND CATALOG NUMBER 15-213CC. ¿ RUPTURE-BREAST: OBSERVED, OPENING ON THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    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. 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: OBSERVED, OPENING ASSESSED AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURE, CREASE, WEAR ABRASION AND NON-PENETRATING WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE. CAPSULECTOMY WAS PERFORMED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE. CAPSULECTOMY WAS PERFORMED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE. CAPSULECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341863 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3170512

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention