BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8297322 · Received February 1, 2019

    Report

    Report Number
    9617229-2019-00326
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 4, 2019
    Report Date
    May 1, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION RESULTS: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH WORK ORDER 2010038 WERE RELEASED IN ACCORDANCE WITH ALLERGAN¿S PROCEDURES, AND NO ANOMALIES WERE FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. REVIEW OF ALL COMPLAINTS FOR THE PERIOD OF MAR 2017 THROUGH FEB 2019 RELATED WITH THE MANUFACTURING DATE AND FOUND NO ADVERSE TREND IN THE EVENT RATE WITH RESPECT TO THE REPORTED EVENT. ACCORDING TO THE DEVICE ANALYSIS PERFORMED IN THE LABORATORY, A SPLIT IN THE PATCH AREA WAS OBSERVED. THIS DEFECT IS CONSIDERED A WORKMANSHIP. THIS CONDITION IS NOT RELATED TO THE REPORTED EVENT. CONSIDERING THAT THERE IS NOT AN ADVERSE TREND FOR THIS EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH SPLIT IN PATCH WILL CONTINUE TO BE MONITORED AND A CORRECTIVE ACTION WILL TAKE IN THE FUTURE IF DEEMED APPROPRIATE. REASON FOR REOPERATION: DEFLATION

    Description of Event or Problem · 0

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

    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.THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    A FURTHER INVESTIGATION (FI) HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED YELLOW PARTICLES IN THE FILL CHANNEL, ONE CURVED OPENING ON THE PATCH AREA, AND A FOLD CREASE. THE LEAK TEST AND MICROSCOPIC ANALYSIS WERE PERFORMED WHICH IDENTIFIED A SPLIT IN THE PATCH AREA. THE OPENING WAS PRODUCED BY THE SPLIT IN THE PATCH AREA, WHICH IS OUT OF SPECIFICATION. THE OPENING WAS IDENTIFIED AS A WORKMANSHIP WHICH IS RELATED TO THE COMPLAINT. THE FILL TEST INSPECTION WAS PERFORMED, AND THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS, THE FINAL ASSESSMENT IS A SPLIT IN THE PATCH AREA THAT CAUSED THE LEAK, WHICH IS ASSESSED AS WORKMANSHIP.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88680 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2010038

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention