BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8614026 · Received May 15, 2019

    Report

    Report Number
    9617229-2019-03357
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 20, 2019
    Report Date
    September 12, 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 · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED BROWN PARTICLES AND OPENING CURVED ON ANTERIOR AND POSTERIOR LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED A STRIATED OPENING ON ANTERIOR AND POSTERIOR, OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA, WEAR ABRASION AND CREASES FOLD. THE FILL TEST INSPECTION WAS PERFORMED WITH THE RESULT OF NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS A STRIATED OPENING ON ANTERIOR AND POSTERIOR DUE TO SURGICAL DAMAGE CONSISTENT IN THE USE OF A SURGICAL TOOL.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "RUPTURE". DEVICE WAS 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. 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

    PATIENT REPORTED RIGHT SIDE "RUPTURE". DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407666 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2419016

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention