BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8580758 · Received May 4, 2019

    Report

    Report Number
    9617229-2019-03076
    Event Type
    Injury
    Date Received
    May 4, 2019
    Date of Event
    January 1, 2018
    Report Date
    June 6, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASES FOLD, WEAR ABRASION AND OPENING CURVED ON POSTERIOR LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: OPENING CREASE SHARP ON ANTERIOR, STRIATED OPENING ON POSTERIOR, OBSERVED VOID ON VALVE SIDE WITHIN SPECIFICATION PER QA199.06 (TEXTURE SIDE) IS NOT CONSIDERED WORKMANSHIP 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 AN OPENING CREASE SHARP ON ANTERIOR DUE TO FOLD FLAW OPENING AND A STRIATED OPENING ON POSTERIOR DUE TO SURGICAL DAMAGE CONSIST IN THE USE OF SOME SURGICAL TOOL.

    Additional Manufacturer Narrative · 1

    THE REASON FOR REOPERATION IS DEFLATION. 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 WAS EXPLANTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374058 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1819578

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention