BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 15051856 · Received July 19, 2022

    Report

    Report Number
    9617229-2022-12062
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    June 20, 2022
    Report Date
    August 25, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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): (B)(4): E2403 NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. DEVICE RETURNED TO DEVICE ANALYSIS LAB. (B)(4): E2403 NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. DEVICE NOT RETURNED. (B)(4): A1401 DEFLATION PROBLEM. DEVICE RETURNED TO DEVICE ANALYSIS LAB. (B)(4): A1401 DEFLATION PROBLEM; E230901 CALCIUM DEPOSITS/ CALCIFICATION. DEVICE RETURNED TO DEVICE ANALYSIS LAB. 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. DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASE FOLD, WHITE PARTICLES INNER THE DEVICE, WEAR ABRASION 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. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718259 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1848178

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention