BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11675046 · Received April 15, 2021

    Report

    Report Number
    9617229-2021-06011
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    May 15, 2018
    Report Date
    July 16, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: "THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON MAY 27, 2021, WITH LOT NUMBER 1830855. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: UNDERWEIGHT, BROWN PARTICLES IN THE SHELL AND BROKEN SHELL. A VISUAL AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: CREASE SHARP BROKEN ON POSTERIOR, CREASE FOLD, WEAR ABRASION AND STRESS MARKS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: AN BROKEN CREASE SHARP ON POSTERIOR ASSESSED AS FOLD FLAW OPENING."

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571704 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1830855

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention