BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8859942 · Received August 5, 2019

    Report

    Report Number
    9617229-2019-10256
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    March 28, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628002708
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INVESTIGATION RESULTS: REVIEW OF STERILIZATION AND SEAL STRENGTH RECORDS RELATED TO THE WORK ORDER DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES THAT MAY BE ASSOCIATED WITH THE REPORTED DEVICE. STERILIZATION PROCESS WAS SUCCESSFULLY COMPLETED AND SEAL STRENGTH TEST RESULTS WERE FOUND TO BE ACCEPTABLE. OTHER RECORDS REVIEWED: ENVIRONMENTAL MONITORING RESULTS FOR (B)(6) 2015, AND BIOBURDEN MONITORING RESULTS FOR ILQ-2015. REVIEW OF WORK ORDER AND THE EVENT CODE "INFECTION" DID NOT IDENTIFY ANY NCMRS, ERS OR CAPA ASSOCIATED WITH THIS INFORMATION. THE REASON FOR REOPERATION WAS INFECTION. THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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

    HEALTH PROFESSIONAL REPORTED LEFT SIDE "SEVERE INFECTION". DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653508 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2728134 10888628002708

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention