BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 22502684 · Received July 14, 2025

    Report

    Report Number
    9617229-2025-11769
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 17, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING SYSTEM IDENTIFIED THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON LOT NUMBER 1424279: 921882: NO COMPLAINT AGAINST THE DEVICE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 1337216: NO COMPLAINT AGAINST THE DEVICE. DEVICE RETURNED TO DEVICE ANALYSIS. 1752372: DEFLATION, PAIN. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 1752374: NO COMPLAINT AGAINST THE DEVICE. DEVICE RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WAS ONE ADDITIONAL COMPLAINTS OF DEFLATION FOR THIS LOT NUMBER, THE DEVICE HAS NOT BEEN RETURNED TO CONFIRM THE EVENT OR TO DETECT A POTENTIAL WORKMANSHIP. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE REV 6.0. THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENT (A050401 FLUID LEAK / BLOOD LEAK). 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: DEVICE DEFLATION.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ DEFLATION: NOT OBSERVED. ¿ VALVE LEAK AND/OR DAMAGE: NOT OBSERVED. 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, CHANGED, AND/OR CORRECTED DATA: A5, B5, B6, D4, D9, H3, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". HEALTHCARE PROFESSIONAL REPORTED LATER BY RGA FORM "VALVE LEAK". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED THROUGH RGA FORM "VALVE LEAK". DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127849 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1424279

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention