BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 20729218 · Received November 19, 2024

    Report

    Report Number
    9617229-2024-24665
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    April 3, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ DEFLATION-USE ERROR: OBSERVED AN OPENING ASSESSED AS SURGICAL DAMAGE PER RGA. ¿ VALVE LEAK AND/ OR DAMAGE: OBSERVED DELAMINATION OF DIAPHRAGM VALVE ASSESSED AS ADHESIVE FAILURE. AS PER THE INVESTIGATION PROCEDURE, CREASES WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: DEFLATION.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED VIA RGA "LEAKY VALVE" AND "SCISSOR TO EDGE OF IMPLANT TO REMOVE THE REST OF THE SALINE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, "DEFLATION". HEALTHCARE PROFESSIONAL, LATER REPORTED, VIA RGA "LEAKY VALVE" AND "SCISSOR TO EDGE OF IMPLANT TO REMOVE THE REST OF THE SALINE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070754 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1066573

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention