BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 9812286 · Received March 10, 2020

    Report

    Report Number
    9617229-2020-03411
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 7, 2020
    Report Date
    July 30, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FI RESULTS: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH WORK ORDER 1103235 WERE RELEASED IN ACCORDANCE WITH ALLERGAN MEDICAL¿S PROCEDURES, AND NO ANOMALIES WERE FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ACCORDING TO THE DEVICE ANALYSIS PERFORMED IN THE LABORATORY, IT WAS OBSERVED A VOID IN VALVE ON SIDE OUT SPECIFICATION, PER QA199.06 (TEXTURE SIDE). THIS OBSERVATION HAS NO RELATION WITH THE REPORTED EVENT. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH VOID IN VALVE WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION : ANALYSIS OF THE RETURNED DEVICE IDENTIFIED FLAT CREASES. LEAK TEST AND MICROSCOPIC ANALYSIS WERE PERFORMED WHICH OBSERVED A VOID ON THE VALVE SIDE OUT OF SPECIFICATION PER QA199.06 (TEXTURE SIDE) AND OBSERVED A VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA. THE FILL TEST INSPECTION WAS PERFORMED, WHICH DETERMINED THE RESULT TO BE THAT NO BLOCKAGE WAS FOUND. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS:VOIDS ON VALVE TEXTURE SIDE AREA, ASSESSED AS A WORKMANSHIP.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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: DEFLATION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273526 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1103235

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention