BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8843927 · Received July 30, 2019

    Report

    Report Number
    9617229-2019-09088
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    September 11, 2017
    Report Date
    July 30, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS RECORD WAS PREVIOUSLY SUBMITTED THRU PSR ON 23/OCT/2017, 22/JAN/2018, AND 23/APR/2018. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S NOTED. DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: YELLOW PARTICLES, CURVED OPENING ON THE ANTERIOR SIDE AND WEIGHT TO THE SPECTRUM. A VISUAL AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED TWO STRIATED OPENING ON THE ANTERIOR SIDE. REASON FOR REOPERATION IS NOT APPLICABLE AS THIS WAS A OUT OF BOX EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "PROSTHESIS RUPTURED DURING IMPLANTATION." SURGERY WAS COMPLETED WITH A BACK-UP DEVICE. SILICONE GEL DID NOT COME INTO CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633930 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2987902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other