BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 15043321 · Received July 18, 2022

    Report

    Report Number
    9617229-2022-12719
    Event Type
    Injury
    Date Received
    July 18, 2022
    Report Date
    August 15, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER EMAIL ADDRESS: (B)(6). 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. THE REASON FOR REOPERATION IS: CONTRALATERAL SIDE DEFLATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENING, BROWN PARTICLES INSIDE OF THE FILL CHANNEL. LEAK TEST WAS PERFORMED AND FOUND OPENING ON RADIUS SIDE. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY A STRIATED EDGE OPENING ON RADIUS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A STRIATED EDGE OPENING ON RADIUS SIDE ASSESSED AS SURGICAL DAMAGE. TREND ANALYSIS SUMMARY: THE COMPLAINT LISTING REPORT INDICATES THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON WORK ORDER 2273618: 1297332: A1401 - DEFLATION PROBLEM. DEVICE RETURNED TO DEVICE ANALYSIS LAB. 1699919: A1401 - DEFLATION PROBLEM. DEVICE NOT RETURNED. 961061: A0401 - BREAK. DEVICE RETURNED TO DEVICE ANALYSIS LAB. 965267: A050401 - FLUID LEAK. DEVICE RETURNED TO DEVICE ANALYSIS LAB. EVEN THOUGH THERE WAS ONE COMPLAINT OF A050401 - FLUID LEAK FOR THIS LOT NUMBER, THE DEVICE WAS RETURNED AND AFTER INSPECTION NO WORKMANSHIP WAS DETECTED. REVIEW OF ALL COMPLAINTS OF A050401 - FLUID LEAK FOR THE PERIOD OF JUL-2022 THROUGH JUN-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 AND ADDITIONAL ANALYSIS¿ ATTACHED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872193 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2273618

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention