BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20019428 · Received August 21, 2024

    Report

    Report Number
    9617229-2024-19212
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    November 15, 2023
    Report Date
    August 20, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    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 EVENT OF SEROMA-LATE, LYMPHADENOPATHY AND RUPTURE WAS RECEIVED ON DECEMBER 04, 2024 WITH LOT NUMBER 3091250. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: LYMPHADENOPATHY: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. SEROMA-LATE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS SURGICAL DAMAGE. AS PER THE INVESTIGATION PROCEDURE CREASES AND WEAR ABRASION WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    CONTINUED E1 (PHONE NUMBER): (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS OF "SEROMA-LATE" AND "LYMPHADENOPATHY" 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: SEROMA-LATE, LYMPHADENOPATHY, DEVICE RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿5-6MM PERIPROSTHETIC COLLECTION ON THE RIGHT BREAST PRESENTING ECOGENIC LINES IN ITS INTERIOR," "SOME IPSILATERAL REACTIVE ADENOPATHY" AND RUPTURE DIAGNOSED VIA ULTRASOUND. THIS RELATES TO THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿5-6MM PERIPROSTHETIC COLLECTION ON THE RIGHT BREAST PRESENTING ECOGENIC LINES IN ITS INTERIOR," "SOME IPSILATERAL REACTIVE ADENOPATHY" AND RUPTURE DIAGNOSED VIA ULTRASOUND. THIS RELATES TO THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300162 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3091250

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention