BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 11634661 · Received April 8, 2021

    Report

    Report Number
    9617229-2021-05397
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TREND REVIEW SUMMARY: THE COMPLAINT LISTING REPORT INDICATES THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON WORK ORDER 2068881: 1981460: NO COMPLAINT AGAINST THE DEVICE. DEVICE RETURNED TO DEVICE ANALYSIS LAB. REVIEW OF ALL COMPLAINTS OF DEFLATION FOR THE PERIOD OF MAR 2019 THROUGH FEB 2021 RELATED TO DATE OPENED INDICATES THAT TWELVE POINTS ARE 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 ¿P-CHART OF DEFLATION FOR SALINE IMPLANTS AND ADDITIONAL ANALYSIS¿ ATTACHED. NO PATTERNS WERE FOUND; THEREFORE, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED. THE TREND OF DEFLATION COMPLAINTS WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASE FLAT AND OPENING ON VALVE. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: CRACK OPENING ON VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A CRACKED VALVE SEAT DIAPHRAGM VALVE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531287 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2068881

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention