BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 21970162 · Received May 6, 2025

    Report

    Report Number
    9617229-2025-07356
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    June 19, 2015
    Report Date
    July 2, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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 1250082: 674843: A010102 - DEVICE APPEARS TO TRIGGER REJECTION, A150202 - MALPOSITION OF DEVICE, E2303 - CAPSULAR CONTRACTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 972899: A010102 - DEVICE APPEARS TO TRIGGER REJECTION. A1401 - DEFLATION PROBLEM, E2303 - CAPSULAR CONTRACTURE. DEVICE RETURNED TO DEVICE ANALYSIS. 1206529: A1401 - DEFLATION PROBLEM. DEVICE NOT RETURNED TO DEVICE ANALYSIS. THE SEARCH CRITERIA OF THIS QUERY ARE MENTIONED IN PROCEDURE 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 /BLOOD LEAK DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS DEFLATION WAS RECEIVED ON MAY 23, 2025, WITH LOT NUMBER 1250082. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: DEFLATION: 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: A2, D9, H3, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832802 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1250082

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown Required Intervention