BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18471835 · Received January 8, 2024

    Report

    Report Number
    9617229-2024-00506
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    February 17, 2022
    Report Date
    January 8, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED ADDITIONAL PHONE NUMBER(S) (E.1): (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN IMPLANT. THIS RECORD RELATES TO THE RIGHT SIDE.

    Description of Event or Problem · 0

    PREVIOUS MEDWATCH SUBMISSION NOTED RUPTURE. UPON FURTHER INFORMATION, ABBVIE HAS DETERMINED THAT THIS RECORD IS A DUPLICATE RECORD. PLEASE SEE MDR 9617229-2023-32315-00 AS THE OPERATING RECORD RELATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590471 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1695646

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention