BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9995156 · Received April 24, 2020

    Report

    Report Number
    9617229-2020-06910
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    December 1, 2011
    Report Date
    June 10, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FI RESULTS: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER 14760478 WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ALLERGAN PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. THE STERILIZATION RUN 117951 IS NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR GEL BREAST IMPLANTS FOR THE PERIOD OF (B)(6) 2018 THROUGH (B)(6) 2020, WAS NOTED AN OUTLIER IN (B)(6) 2018. AN ADDITIONAL ANALYSIS WAS PERFORMED TO DETERMINE ANY PATTERN OR ANY SIMILARITIES RELATION BETWEEN PR¿S INVOLVED. IT WAS FOUND THAT ONE PRIMARY PACKAGING OPERATOR WAS INVOLVED IN MORE THAN ONE OCCASION, HOWEVER THE PERSON WAS TRAINED IN THE CORRESPONDING PROCEDURE. ALSO, CALIBRATIONS, MAINTENANCE AND VALIDATIONS OF THE EQUIPMENT INVOLVED IN MORE THAN ONE OCCASION WERE REVIEWED AND IT WAS DETERMINED THAT THEY WERE PERFORMED ON TIME AND MET SPECIFICATIONS. IN ADDITION, ALL THE RECORDS INVOLVED IN THIS MONTH WERE REVIEWED AND NO ISSUES WERE FOUND ASSOCIATED TO EITHER EVENT. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO THE MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT REPORTED A RIGHT SIDE INFECTION. HEALTHCARE PROFESSIONAL REPORTED ADDITIONAL EVENT OF PAIN. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 01/23/2013. 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. 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. REASON FOR REOPERATION: BREAST PAIN.

    Description of Event or Problem · 1

    PATIENT REPORTED A RIGHT SIDE INFECTION. HEALTHCARE PROFESSIONAL REPORTED ADDITIONAL EVENT OF PAIN. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461389 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1798484

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention