BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8705550 · Received June 17, 2019

    Report

    Report Number
    9617229-2019-06341
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 13, 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 Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION:VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: FOLD CREASES, WEAR ABRASION, LINEAR OPENING. A LEAK TEST WAS PERFORMED AND WAS FOUND ONE OPENING. A MICROSCOPIC ANALYSIS IDENTIFIED: A LINEAR SMOOTH OPENING ON POSTERIOR SIDE IN THE SAME LOCATION OF CREASE ASSESSED AS FOLD FLAW OPENING. FILL INSPECTION WAS PERFORMED AND IDENTIFIED NO BLOCKAGE IN THE VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SMOOTH CREASE OPENING ASSESSED AS FOLD FLAW OPENING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION AND CREASE/FOLDING OF THE IMPLANT. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    CLARIFICATION TO: HEALTHCARE (HCP) PROFESSIONAL PROVIDED SNS (B)(4). HCP WAS UNABLE TO CONFIRM WHICH DEVICE WAS INVOLVED IN THE REPORTED EVENT. 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 WAS FOR DEFLATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION AND CREASE/FOLDING OF THE IMPLANT. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498375 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1037330

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention