BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20177239 · Received September 9, 2024

    Report

    Report Number
    9617229-2024-20328
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. PHONE NUMBER CONTINUED: (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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE, PAIN, VISIBILITY/PALPABILITY.

    Additional Manufacturer Narrative · 0

    PHOTO EVALUATION: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, PAIN AND VISIBILITY/PALPABILITY REQUESTED ON SEP 10, 2024. WITH LOT NUMBER 2760778 AND CATALOG N-TSM345: RUPTURE: OBSERVED, OPENING ON THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. PAIN: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. VISIBILITY/PALPABILITY: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "BREAST ASYMMETRY, PAIN IN THE RIGHT BREAST AREA. THE EXAMINATION REVEALED A CHANGE IN THE SHAPE OF THE BREAST, A CHANGE IN DENSITY, AND PAIN DURING PALPATION". BREAST MAGNETIC RESONANCE IMAGING (MRI) WAS ROUTINELY PERFORMED WHICH CONFIRMED THE RIGHT IMPLANT RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "BREAST ASYMMETRY, PAIN IN THE RIGHT BREAST AREA. THE EXAMINATION REVEALED A CHANGE IN THE SHAPE OF THE BREAST, A CHANGE IN DENSITY, AND PAIN DURING PALPATION". BREAST MAGNETIC RESONANCE IMAGING (MRI) WAS ROUTINELY PERFORMED WHICH CONFIRMED THE RIGHT IMPLANT RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331003 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2760778

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention