BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 13367412 · Received January 27, 2022

    Report

    Report Number
    9617229-2022-00144
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    September 1, 2021
    Report Date
    January 27, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607285
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT - PATIENT'S YEAR OF BIRTH: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF LYMPHADENOPATHY 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: PROMINENT AXILLARY LYMPH NODES WITH ENLARGED CORTEX.

    Additional Manufacturer Narrative · 0

    "DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF LYMPHADENOPATHY WAS RECEIVED ON (B)(6) 2022 WITH LOT NUMBER 2903083. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, DEFORMATION, AND RED PARTICLES IN THE SURFACE OF THE SHELL. CLOUDY WAS OBSERVED AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PROMINENT AXILLARY LYMPH NODES WITH ENLARGED CORTEX MOST LIKELY CAUSED BY COVID-19 VACCINATION". DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PROMINENT AXILLARY LYMPH NODES WITH ENLARGED CORTEX MOST LIKELY CAUSED BY COVID-19 VACCINATION". DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233322 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2903083 05060191607285

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention