BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12676954 · Received October 21, 2021

    Report

    Report Number
    9617229-2021-54342
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    February 11, 2020
    Report Date
    December 6, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607674
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED. LOT NUMBER IN THE PATCH: 2951806 AND CATALOG: TSM310G. OBSERVED OPENING ON POSTERIOR SIDE. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED FOR LEFT SIDE "AN INTRA AND EXTRA-CAPSULAR RUPTURE ON LEFT SIDE." AND "SILICON LYMPHADENOPATHY ON LEFT AXILLA AND LEFT PARASTERNAL LYMPH NODE CHAINS". DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Additional Manufacturer Narrative · 1

    HEALTH EFFECT IMPACT CODE CONT: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENT OF "SILICON LYMPHADENOPATHY" IS PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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

    HEALTHCARE PROFESSIONAL REPORTED FOR LEFT SIDE "AN INTRA AND EXTRA-CAPSULAR RUPTURE ON LEFT SIDE." AND "SILICON LYMPHADENOPATHY ON LEFT AXILLA AND LEFT PARASTERNAL LYMPH NODE CHAINS". DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570159 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2951806 05060191607674

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention