BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11504898 · Received March 17, 2021

    Report

    Report Number
    9617229-2021-04669
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    November 1, 2019
    Report Date
    May 4, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628003767
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INVESTIGATION FINDINGS: ENVIRONMENTAL MONITORING RESULTS FOR NOVEMBER 2015 WERE REVIEWED AND ALL RESULTS WERE FOUND ACCEPTABLE. BIOBURDEN TESTING RESULTS FOR THE NOVEMBER 2015 WERE FOUND TO BE ACCEPTABLE. THE REVIEW OF THE STERILIZATION RECORDS DEMONSTRATED ACCEPTABLE RESULTS THEREFORE NO TRAINING REVISION WAS REQUIRED FOR THIS PROCESS. THE COMPLAINT LISTING REPORT INDICATES THAT THERE WERE NO OTHER RECORDS RELATED TO THIS EVENT FOR UNITS MANUFACTURED ON WORK ORDER 2830411 AND STERILIZED UNDER STERILIZATION RUN 30021342. WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER (B)(6) 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 30021342 NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO 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 RIGHT SIDE "CONCERN WITH THE TEXTURED IMPLANTS." PATIENT ADDITIONALLY REPORTED RIGHT SIDE RUPTURE AND INFECTION. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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 REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 AND INFECTION. 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.

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT SIDE "CONCERN WITH THE TEXTURED IMPLANTS." PATIENT ADDITIONALLY REPORTED RIGHT SIDE RUPTURE AND INFECTION. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402816 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) MX-410520 2830411 10888628003767

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention