BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19581068 · Received June 21, 2024

    Report

    Report Number
    9617229-2024-15517
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    October 17, 2023
    Report Date
    June 20, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONT E1 PHONE NUMBER - (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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: RUPTURE, "QUANTITY OF FLUID ADJACENT TO THE PROSTHESES"

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE, "QUANTITY OF FLUID ADJACENT TO THE PROSTHESES" AND "SOLID NODULE LOCATED IN THE QIM". DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164130 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3133519

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention