BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 14986776 · Received July 12, 2022

    Report

    Report Number
    9617229-2022-11720
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    June 15, 2022
    Report Date
    August 9, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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: DEFLATION.

    Additional Manufacturer Narrative · 0

    TREND REVIEW SUMMARY: THE COMPLAINT LISTING REPORT INDICATES THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON WORK ORDER (B)(4): 45989: NO INFORMATION. DEVICE RETURNED TO DEVICE ANALYSIS LAB. 207999: NO INFORMATION. DEVICE NOT RETURNED. 2596841: A050401 - FLUID LEAK. DEVICE NOT RETURNED. EVEN THOUGH THERE WAS ONE COMPLAINT OF A050401 - FLUID LEAK FOR THIS LOT NUMBER, THE DEVICE HAS NOT BEEN RETURNED TO CONFIRM THE EVENT OR TO DETECT A POTENTIAL WORKMANSHIP. REVIEW OF ALL COMPLAINTS OF A050401 - FLUID LEAK FOR THE PERIOD OF JUN 2020 THROUGH MAY 2022 RELATED TO DATE OPENED INDICATES THAT 1 POINT IS ABOVE THE UPPER CONTROL LIMIT. ACCORDING TO THE SEVERITY, AN ADDITIONAL ANALYSIS WAS PERFORMED TO REVIEW THE INVOLVED COMPLAINTS WITH MANUFACTURING DATE OVER THE PAST 24 MONTHS. SEE ¿I CHART OF A050401 FLUID LEAK FOR SALINE BREAST IMPLANTS¿ ATTACHED. NO PATTERNS WERE FOUND; THEREFORE, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED. THE TREND OF A050401 - FLUID LEAK COMPLAINTS WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED A RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED A RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652584 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 552777

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention