BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16837506 · Received April 28, 2023

    Report

    Report Number
    9617229-2023-07127
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    February 15, 2023
    Report Date
    April 28, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191606639
    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

    CONTINUED H6: F2203 - IMAGING REQUIRED. CONTINUED PHONE NUMBER(S) (E.1):(B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN/WILL BE INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: ULTRASOUND DIAGNOSED AN "INTRA CAPSULAR RUPTURE". VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. LUMP/NODULE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. PATCH LOT NUMBER 3150545.

    Description of Event or Problem · 0

    PHYSICIAN PROVIDED AN ULTRASOUND WHICH DIAGNOSED AN "INTRA CAPSULAR RUPTURE". PHYSICIAN ADDITIONALLY REPORTED ¿PRESENT NODULE IN CIE ... OF THE RIGHT BREAST OF ABOUT 0.5 CM IN DIAMETER OF ELASTIC CONSISTENCY, BOTHERSOME TO PALPATION¿ AND ¿NODULES¿. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RELATES TO THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833047 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3150545 05060191606639

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention