BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12683865 · Received October 22, 2021

    Report

    Report Number
    9617229-2021-53601
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 1, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, WAS RECEIVED ON DEC 29, 2021 WITH LOT NUMBER 2242951. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: BROKEN SHELL AND UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: SHARP BROKEN ON RADIUS. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: SHARP BROKEN ON RADIUS ASSESSED AS UNIDENTIFIED (TEAR) OPENING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576597 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2242951

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention