BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9457188 · Received December 12, 2019

    Report

    Report Number
    9617229-2019-19529
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    August 8, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628002999
    PMA / PMN Number
    P040046
    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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. THE REASON FOR REOPERATION WAS/IS PAINC. THE EVENT REPORTED IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A DEFORMATION AND CREASES. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE WAS WITHIN SPECIFICATION. CLOUDY AND VOIDS AFTER AUTOCLAVE DISINFECTION PROCESS IN THE GEL. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND CHRONIC DISCOMFORT/PAIN OF BILATERAL UPPER OUTER BREASTS. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255257 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2780874 10888628002999

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention