BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15764528 · Received November 9, 2022

    Report

    Report Number
    9617229-2022-21069
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    May 1, 2022
    Report Date
    March 20, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607278
    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

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS CAPSULAR CONTRACTURE AND GRANULOMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: CAPSULAR CONTRACTURE BAKER GRADE III, GRANULOMA.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. GRANULOMA: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. IT CANNOT BE DETERMINED WHICH DEVICE IS FOR THE LEFT OR RIGHT SIDE PER THE PHOTOS PROVIDED. REFER TO PS-QP-ONEV-115717: COVID-19 QUALITY PLAN - COMPLAINT HANDLING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3" AND "HETEROGENEOUS INTRACAPSULAR TISSUE AND WITH CARDIO-CONTRAST ENHANCEMENT, FINDINGS CONSISTENT WITH SILICONE-INDUCED GRANULOMA" THIS IS FOR THE RIGHT SIDE. THE DEVICE STILL REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3" AND "HETEROGENEOUS INTRACAPSULAR TISSUE AND WITH CARDIO-CONTRAST ENHANCEMENT, FINDINGS CONSISTENT WITH SILICONE-INDUCED GRANULOMA" THIS IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "HETEROGENEOUS INTRACAPSULAR TISSUE AND WITH CARDIO-CONTRAST ENHANCEMENT, FINDINGS CONSISTENT WITH SILICONE-INDUCED GRANULOMA." THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2952068 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2436817 05060191607278

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention