BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11655031 · Received April 13, 2021

    Report

    Report Number
    9617229-2021-05784
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    January 1, 2020
    Report Date
    January 11, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191606554
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, CREASE FOLDING OF IMPLANT, MIGRATION, PAIN AND ANXIETY-PRODUCT/PROCEDURE WAS RECEIVED ON (B)(6) 2022, WITH LOT NUMBER 2243047. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: NO OBSERVED OPENING ON THE DEVICE. MIGRATION: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. PAIN: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ANXIETY-PRODUCT/PROCEDURE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. CREASE FOLDING OF IMPLANT: CREASE FOLD OBSERVED ON THE DEVICE. ADDITIONAL OBSERVATIONS: NO OTHER OBSERVATION OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTS "THEY BELIEVE THAT ONE OF THEM HAS RUPTURED, I AM WAITING ON SOME RESULTS FROM MY DOCTORS¿. PATIENT FURTHER REPORTED ¿I WENT TO THE HOSPITAL AND THEY FOUND A FOLD IN ONE MY IMPLANTS AND THE LEFT ONE HAS DROPPED OUT OF ITS POCKET AND ADVISED ME TO NOT LEAVE HAVING SURGERY TOO LONG BUT IT IS NOT A MATTER OF URGENCY". ALSO REPORTED "FINALLY PUT DOWN TO THE SEVERE PAIN I WAS HAVING THIS WHOLE TIME." THIS RELATES TO THE LEFT DEVICE. 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: "RUPTURED".

    Description of Event or Problem · 1

    PATIENT REPORTS LEFT SIDE IMPLANT "HAS RUPTURED." DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553925 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2243047 05060191606554

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention