BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 19710098 · Received July 10, 2024

    Report

    Report Number
    9617229-2024-16531
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 3, 2024
    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

    LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENTS DEFLATION WAS RECEIVED ON JULY 18, 2024, WITH LOT NUMBER 3191807. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: DEFLATION: OBSERVED, 1 OPENING ASSESSED, FOLD FLOW OPENING. AS PER THE INVESTIGATION PROCEDURE: CREASES AND WEAR ABRASION WAS COMPLETED. 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: DEFLATION.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, "DEFLATION AND EXCHANGE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND EXCHANGE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472522 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 3191807

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention