BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 22423673 · Received July 7, 2025

    Report

    Report Number
    9617229-2025-11279
    Event Type
    Injury
    Date Received
    July 7, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000469
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 WAS ANOTHER RECORD FOR UNITS MANUFACTURED ON LOT NUMBER 1252503: (B)(4): A25 NO APPARENT ADVERSE EVENT. DEVICE NOT RETURNED TO DEVICE ANALYSIS. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE 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

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF DEFLATION WAS RECEIVED ON JULY 15, 2025, WITH LOT NUMBER 1252503. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: DEFLATION: OBSERVED AN OPENING ASSESSED AS SURGICAL DAMAGE. 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: D9, H3, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND THE EVENT WAS FIRST NOTICED BY THE PATIENT WITHIN A WEEK OF IMPLANTATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND THE EVENT WAS FIRST NOTICED BY THE PATIENT WITHIN A WEEK OF IMPLANTATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163652 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1252503 10888628000469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention