BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10689458 · Received October 16, 2020

    Report

    Report Number
    9617229-2020-16830
    Event Type
    Injury
    Date Received
    October 16, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF INFECTION (UNKNOWN ONSET) 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: INFECTION (UNKNOWN ONSET).

    Description of Event or Problem · 1

    PATIENT REPORTED "FEEL PAIN WHENEVER I LIE DOWN ON MY CHEST", "OCCASIONALLY FEEL A STABBING SENSATION ON MY BREASTS", "WHENEVER I'M IN THE SHOWER, I CAN PALPATE A JELLY-LIKE SUBSTANCE UNDER MY BREAST WHERE THE SCAR IS", "MY BLOOD EXAMS ALSO SHOW I HAVE AN INFECTION, BUT WE CAN'T FIGURE IT OUT", "EXTREMELY ANXIOUS DUE TO MY FAMILY HISTORY OF CANCER AND THE SIGNS AND SYMPTOMS MENTIONED", "CAUSING ME A LOT OF STRESS", PSYCHOLOGICAL DAMAGE, DOESN'T FEEL SAFE, PATIENT DOESN¿T WANT TO STAY WITH THE PROSTHESIS, "NOT POSSIBLE TO LIVE WITH THIS ANGUISH AND PRETEND DOESN¿T KNOW ABOUT THE RECALL". "ONE OF MY TOES IS ALSO INFLAMED, AND NO ONE CAN EXPLAIN WHY" ALSO REPORTED, BUT NOT DEVICE RELATED. THE DEVICE REMAINS IMPLANTED. LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158089 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3121370

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BIRTH CONTROL