BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14408697 · Received May 16, 2022

    Report

    Report Number
    9617229-2022-07895
    Event Type
    Injury
    Date Received
    May 16, 2022
    Date of Event
    March 16, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628002340
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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: RUPTURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: UNDERWEIGHT AND BROKEN SHELL. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: SHARP BROKEN ON POSTERIOR. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: SHARP BROKEN ON POSTERIOR ASSESSED AS UNIDENTIFIED (TEAR) OPENING.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿LEAKAGE AND TRAPPING OF SILICON IN INTRAMAMMARY LNS AND AXILLARY LNS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091589 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 115-222 2699343 10888628002340

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention