BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20302147 · Received September 25, 2024

    Report

    Report Number
    9617229-2024-21385
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    July 1, 2024
    Report Date
    December 19, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE/ EDEMA/BREAST PAIN WAS RECEIVED ON OCT 01, 2024, WITH LOT NUMBER 3210949. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ RUPTURE: OPENING DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WAS WITHIN SPECIFICATION). ¿ EDEMA: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ BREAST PAIN: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE CREASE PARTICLES 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

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTION, AND/OR CHANGED DATA: D.4, H.4.

    Description of Event or Problem · 0

    PATIENT REPORTED DEVICE RUPTURE DIAGNOSED VIA ULTRASOUND AND CONFIRMED DURING SURGERY. SUBSEQUENTLY, PHYSICIAN REPORTED SWELLING, PAIN, STINGING AND BURNING SENSATION IN BREAST. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THIS RELATES TO AN UNKNOWN SIDE.

    Description of Event or Problem · 0

    PATIENT REPORTED DEVICE RUPTURE DIAGNOSED VIA ULTRASOUND AND CONFIRMED DURING SURGERY. SUBSEQUENTLY, PHYSICIAN REPORTED SWELLING, PAIN, STINGING AND BURNING SENSATION IN BREAST. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THIS RELATES TO AN UNKNOWN SIDE

    Description of Event or Problem · 0

    PATIENT REPORTED DEVICE RUPTURE DIAGNOSED VIA ULTRASOUND AND CONFIRMED DURING SURGERY. SUBSEQUENTLY, PHYSICIAN REPORTED SWELLING, PAIN, STINGING AND BURNING SENSATION IN BREAST. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THIS RELATES TO AN UNKNOWN SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243858 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3210949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention