BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 22502105 · Received July 14, 2025

    Report

    Report Number
    9617229-2025-11756
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 3, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 560956: 1238967: DEFLATION. DEVICE RETURNED TO DEVICE ANALYSIS. 1308823: DEFLATION AND CREASE/FOLDING OF IMPLANT - NDR. DEVICE RETURNED TO DEVICE ANALYSIS. 140707: DEFLATION. DEVICE RETURNED TO DEVICE ANALYSIS. 154936: DEFLATION. DEVICE RETURNED TO DEVICE ANALYSIS. 834698: ASYMMETRY - NDR. DEVICE RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WERE 4 ADDITIONAL COMPLAINTS OF DEFLATION FOR THIS LOT NUMBER, THE DEVICES WERE RETURNED, AND AFTER INSPECTION NO WORKMANSHIP WERE DETECTED. THE SEARCH CRITERIA FOR THESE QUERIES ARE MENTIONED IN QPP07-01-004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE AND REVISION 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/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

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5; D6B; H6.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION: OBSERVED DELAMINATION OF DIAPHRAGM VALVE ASSESSED AS ADHESIVE FAILURE. AS PER THE INVESTIGATION PROCEDURES, CREASES WERE COMPLETED 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: B5, D4, D9, H3, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATION." HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE IN VALVE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395182 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 560956

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention