BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22189654 · Received June 11, 2025

    Report

    Report Number
    9617229-2025-09710
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 12, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191607278
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF RUPTURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON JULY 17, 2025, WITH LOT NUMBER 2872015. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ RUPTURE: OBSERVED AN OPENING ASSESSED AS SURGICAL DAMAGE. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASES WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE II

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE II. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE II. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87770 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2872015 5060191607278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention