BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 11611215 · Received April 2, 2021

    Report

    Report Number
    9617229-2021-06535
    Event Type
    Injury
    Date Received
    April 2, 2021
    Report Date
    June 7, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CURVED OPENINGS, FLAT CREASES, OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: TWO CURVED STRIATED OPENINGS ON ANTERIOR SIDE ASSESSED AS SURGICAL DAMAGE. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: CURVED STRIATED OPENINGS ASSESSED AS SURGICAL DAMAGE CONSIST IN THE USE OF SOME SURGICAL TOOL.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE DEFLATION, "BREAST DEFORMATION", ¿BREAST WAS CHANGING SHAPE¿, AND PAIN. HEALTHCARE PROFESSIONAL CONFIRMED DEFLATION AND "BREAST DEFORMATION". 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, "BREAST DEFORMATION", ¿BREAST WAS CHANGING SHAPE¿, AND PAIN.

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT SIDE DEFLATION, "BREAST DEFORMATION", ¿BREAST WAS CHANGING SHAPE¿, AND PAIN. HEALTHCARE PROFESSIONAL CONFIRMED DEFLATION AND "BREAST DEFORMATION". DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507814 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2158603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention