BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12291023 · Received August 6, 2021

    Report

    Report Number
    9617229-2021-48232
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    November 15, 2020
    Report Date
    September 30, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED ONE EXTENDED OPENING, RED PARTICLES MATERIAL WAS FOUND ON THE SHELL AND FOLD CREASES. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED ONE OPENING SHARP AND WEAR ABRASION. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: ONE SHARP OPENING IN THE SIDE RADIUS ASSESSED AS UNIDENTIFIED (TEAR) OPENING.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED A RIGHT SIDE "IMPLANT RUPTURE" DIAGNOSED BY MRI. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER NAME AND ADDRESS: (B)(6). VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED. DEVICE PATCH WITH LOT (OR CATALOG) NUMBER LOT NUMBER: 2032075. RED PARTICLES PARTICLE MATERIAL ON THE SHELL. OPENING EXTENDED ON RADIUS. 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

    PHYSICIAN REPORTED "IMPLANT RUPTURE". DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183422 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2032075

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention