BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8517798 · Received April 16, 2019

    Report

    Report Number
    9617229-2019-02402
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 21, 2019
    Report Date
    July 18, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED FOLD CREASES AND WEAR ABRASION. A LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED A STRIATED PUNCTURE ON THE ANTERIOR, AN OPENING SHARP CREASE ON THE ANTERIOR, NON-PENETRATING NICKS AND OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS A STRIATED PUNCTURED ON ANTERIOR DUE TO SURGICAL DAMAGE LIKE CONSIST IN THE USE OF SOME SURGICAL TOOL AND AN OPENING CREASE SHARP ON ANTERIOR DUE TO FOLD FLAW OPENING REASON FOR REOPERATION IS DEFLATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 1

    PATIENT REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312516 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2475561

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention