BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11718533 · Received April 23, 2021

    Report

    Report Number
    9617229-2021-06439
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 15, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, G2, H6.

    Additional Manufacturer Narrative · 0

    PHOTOGRAPH ANALYSIS: VISUAL ANALYSIS OF THEN IDENTIFIED A FULLY ENCAPSULATED DEVICE, IT APPEARS TO BE INTACT WITH THE LOT NUMBER 3163402. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE. REFER TO PS-QP-ONEV-115717: COVID-19 QUALITY PLAN - COMPLAINT HANDLING.

    Description of Event or Problem · 0

    HCP REPORTED ADDITIONALLY REPORTED "MAMMARY DEFORMATION, PAINS, DENSIFICATION". DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT IMPLANT CAPSULAR CONTRACTURE BAKER GRADE III AND "ANECHOGENIC LIQUID/SEROMA." PHYSICIAN CONFIRMS "MAMMARY DEFORMATION, PAINS, DENSIFICATION". DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS ARE 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: CAPSULAR CONTRACTURE BAKER GRADE III AND "ANECHOGENIC LIQUID/SEROMA."

    Description of Event or Problem · 1

    PATIENT REPORTS RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III", "MULTIPLE IMPLANT FOLDS" AND "ANECHOGENIC LIQUID/SEROMA." DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611465 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3163402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention