BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10982110 · Received December 10, 2020

    Report

    Report Number
    9617229-2020-20291
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 8, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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: VISUAL ANALYSIS OF THE PHOTOS IDENTIFIED BROWN PARTICLE MATERIAL ON THE SHELL AND AN OPENING. DEVICE PATCH WITH LOT NUMBER 2900709. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS AS IT WAS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED "DURING A ROUTINE VISUAL EXAMINATION - SUSPECTED LEFT IMPLANT RUPTURE. DURING THE SURGERY RUPTURE CONFIRMED". THIS RELATES TO THE LEFT 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

    PHYSICIAN REPORTED RUPTURE, UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454131 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2900709

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention