BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 9424258 · Received December 6, 2019

    Report

    Report Number
    9617229-2019-19501
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    December 13, 2018
    Report Date
    April 1, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000193
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION, RECEIVED ON MAR 04, 2020 WITH LOT NUMBER 2930363. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASE FOLD, WEAR ABRASION, YELLOW PARTICLES IN THE SHELL, BROWN PARTICLES IN THE FILL CHANNEL AND ONE OPENING LINEAR ON THE POSTERIOR. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: ONE OPENING CREASE SHARP ON THE POSTERIOR. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: - ONE CREASE SHARP OPENING ON THE POSTERIOR ASSESSED AS FOLD FLAW OPENING. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5, D.7, D.10, G.1, H.3, H.6.

    Description of Event or Problem · 0

    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: WILL BE DEFLATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220040 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 68-240 2930363 10888628000193

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention