BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11087388 · Received December 29, 2020

    Report

    Report Number
    9617229-2020-21252
    Event Type
    Injury
    Date Received
    December 29, 2020
    Report Date
    March 11, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE ANALYSIS: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON(B)(6), 2021 WITH LOT NUMBER 2070644. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: UNDERWEIGHT, WEAR ABRASION, BROWN PARTICLES IN THE SHELL, BROKEN ON POSTERIOR AND MISSING SHELL (0-25%). A VISUAL AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: CREASES SHARP BROKEN IN THE SHELL, STRESS MARK AND CREASES FLAT. BASE ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A PATTERN OF CREASE SHARP ON POSTERIOR SIDE OF BROKEN SHELL ASSESSED AS FOLD FLAW OPENING. MISSING SHELL ASSESSED AS INCONCLUSIVE.

    Description of Event or Problem · 0

    MEDICAL STAFF REPORTED RUPTURE, UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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

    MEDICAL STAFF REPORTED RUPTURE, UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552951 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2070644

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention