BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16471091 · Received March 2, 2023

    Report

    Report Number
    9617229-2023-04105
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    January 6, 2023
    Report Date
    March 2, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607261
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE THAT FEELS PAIN ON BOTH SIDES, BEING STRONGER ON THE LEFT SIDE. REPORTED THAT THE PAIN STARTS IN THE ARMPITS, AND HAS BEEN PROGRESSING, ALSO LEAVING THE AREOLA SENSITIZED¿, ¿THERE IS A PERCEPTION THAT THE LEFT BREAST IS BIGGER THAN THE RIGHT¿,¿SPARSE BENIGN CALCIFICATIONS¿, ¿LOBULATED CONTOURS¿, AND ¿THIN LAYER OF PERIPROSTHETIC FLUID¿. DEVICE REMAINS IMPLANTED. ¿NODULE IN THE UPPER OUTER QUADRANT OF THE LEFT BREAST WITH BENIGN FINDINGS¿ AND "IMAGES OF CYSTIC ASPECT IN QIM OF THE LEFT BREAST, MEASURING - ABOUT 0.48 CM AND IN QSL OF THE LEFT BREAST, MEASURING ABOUT 0.43 CM¿ ARE NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825843 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2722390 05060191607261

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention