BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18969440 · Received March 25, 2024

    Report

    Report Number
    9617229-2024-05057
    Event Type
    Injury
    Date Received
    March 25, 2024
    Report Date
    August 2, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: DEVICE PATCH WITH LOT NUMBER 2050531 AND CATALOG NUMBER 110-210G. 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.

    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 DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE-BREAST: OBSERVED BROKEN DEVICE ASSESSED AS SURGICAL IMPACT OPENING (SHELL THICKNESS WITHIN SPECIFICATION) AND ONE OPENING ASSESSED AS SURGICAL DAMAGE. AS PER THE INVESTIGATION PROCEDURE NON-PENETRATING NICK WERE 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

    PHYSICIAN REPORTED LEFT SIDE RUPTURE, CONFIRMED BY ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED LEFT SIDE RUPTURE, CONFIRMED BY ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED LEFT SIDE RUPTURE, CONFIRMED BY ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436177 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2050531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention