BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 15192758 · Received August 9, 2022

    Report

    Report Number
    9617229-2022-13119
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 28, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. TREND ANALYSIS SUMMARY: 267591: A1401 DEFLATION PROBLEM. DEVICE RETURNED TO DEVICE ANALYSIS LAB. 562799: A1401 DEFLATION PROBLEM. DEVICE RETURNED TO DEVICE ANALYSIS LAB. 2043849: A1401 DEFLATION PROBLEM, A050401 FLUID LEAK. DEVICE ANALYSIS THROUGH PHOTOS. 2609442: E2403 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, A25 NO APPARENT ADVERSE EVENT. DEVICE NOT RETURNED. EVEN THOUGH THERE WAS ONE COMPLAINT OF A050401 FLUID LEAK FOR THIS LOT NUMBER, THE DEVICE WAS ANALYZED AND AFTER INSPECTION NO WORKMANSHIP WAS DETECTED.REVIEW OF ALL COMPLAINTS OF FLUID LEAK (A050401) FOR THE PERIOD OF JUL 2020 THROUGH JUN 2022 RELATED TO DATE OPENED INDICATES THAT ONE 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 FLUID LEAK (A050401) COMPLAINTS WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASES FOLD, WEAR ABRASION AND OPENING CURVED ON POSTERIOR. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: STRIATED OPENING ON POSTERIOR AND SHARP OPENING ON VALVE BOND EDGE. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A STRIATED OPENING ON POSTERIOR ASSESSED AS SURGICAL DAMAGE A SHARP OPENING ON VALVE BOND EDGE ASSESSED AS AN UNIDENTIFIED (TEAR) OPENING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249500 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1422781

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention