BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18015286 · Received October 26, 2023

    Report

    Report Number
    9617229-2023-17535
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    August 15, 2023
    Report Date
    February 22, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191606769
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOGRAPHIC DEVICE EVALUATION: A REVIEW OF THE DEVICE THROUGH PHOTOS NOTED RUPTURE COULD BE OBSERVED. MICROANALYSIS CAN NOT BE PERFORMED AND AN ASSESSMENT OF THE OPENING CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. PAIN: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT THAT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED. DEVICE EVALUATION:BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED 1 OPENING ASSESSED AS SURGICAL DAMAGE. PAIN: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. NO OTHER OBSERVATIONS OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    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 PATIENT DETAILS AND DEVICE RETURN HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE. CONTINUED H6 (IMPACT CODE): F2201.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN, ¿COLLAPSE WITH PALPATION¿, ¿THE FORMATION OF INTROCESSION ON PALPATION EXAMINATION¿, AND ¿BREAST DEVICE HAD BROKEN DOWN AND THE ENTIRE CONTENTS OF THE PROSTHESIS HAD FLOWED INTO THE LOJ". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN, ¿COLLAPSE WITH PALPATION¿, ¿THE FORMATION OF INTROCESSION ON PALPATION EXAMINATION¿, AND ¿BREAST DEVICE HAD BROKEN DOWN AND THE ENTIRE CONTENTS OF THE PROSTHESIS HAD FLOWED INTO THE LOJ". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN, ¿COLLAPSE WITH PALPATION¿, ¿THE FORMATION OF INTROCESSION ON PALPATION EXAMINATION¿, AND ¿BREAST DEVICE HAD BROKEN DOWN AND THE ENTIRE CONTENTS OF THE PROSTHESIS HAD FLOWED INTO THE LOJ". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733897 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3154490 05060191606769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention