BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8901023 · Received August 16, 2019

    Report

    Report Number
    9617229-2019-10058
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    December 6, 2018
    Report Date
    October 15, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BEYOND 30-CALENDAR DAYS FROM ALLERGAN¿S RECEIPT DUE TO THE EXEMPTION TRANSITION PERIOD. ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. CLARIFICATION TO D4: DEVICE LOT NUMBER PROVIDED AS 183325. THIS DOES DETAIL DOES NOT IDENTIFY A CORRESPONDING DEVICE IN OUR SYSTEM.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER ADDITIONALLY REPORTED "PRESENCE OF SEVERAL SNOWSTORM IMAGES OF AT LEAST 3 IN THE AXILLARY HOLLOW, THE LARGEST OF WHICH IS ESTIMATED TO BE AROUND 10 MM, THE ELEMENTARY ASPECT OF WHICH EVOKES SILICONOMAS¿.

    Additional Manufacturer Narrative · 1

    THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION: RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV. 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

    PHYSICIAN REPORTED A FORTUITOUS RUPTURE AND A CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696907 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention