BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17054370 · Received June 2, 2023

    Report

    Report Number
    9617229-2023-09960
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    April 21, 2023
    Report Date
    October 30, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191606783
    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

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED, AN OPENING ON POSTERIOR ASSESSED, AS AN UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WITHIN SPEC). ADDITIONAL OBSERVATIONS: OBSERVED, 40 MM DARK PATCH EDGE MATERIAL INSIDE GEL DEVICE. BROWN PARTICLES OBSERVED, ON THE DEVICE.

    Additional Manufacturer Narrative · 0

    CONTINUED HEALTH EFFECT - IMPACT CODE 4: F1903. 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. MW 2770997 / MDR REPORT NUMBER 9617229-2023-09052: CAPTURES THE EVENT OF RUPTURE FOR CONTRALATERAL SIDE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED RUPTURE DIAGNOSED BY MRI. UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE DIAGNOSED BY MRI. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE RUPTURE. DIAGNOSED BY MRI. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE REPORTED RUPTURE. UNKNOW SIDE.DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089243 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2522282 05060191606783
    1405706 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2522282 05060191606783

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention