BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9587089 · Received January 14, 2020

    Report

    Report Number
    9617229-2019-23496
    Event Type
    Injury
    Date Received
    January 14, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628033184
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON JAN 16, 2020 WITH LOT NUMBER 3121662. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED WEIGHT TO THE SPEC, OPENING, CREASE FOLD, RED PARTICLES. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY A STRIATED EDGE OPENING, CONSIST WITH USE OF A SURGICAL TOOL. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS A STRIATED EDGE OPENING ON ANTERIOR SIDE DUE TO SURGICAL DAMAGE. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D10, G1, G4, H3, H6.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    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 RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50640 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) SSF-485 3121662 10888628033184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention