BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12125287 · Received July 6, 2021

    Report

    Report Number
    9617229-2021-46803
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    January 20, 2021
    Report Date
    September 23, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON AUGUST 12, 2021 WITH LOT NUMBER 2900844. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED WEAR ABRASION, VOIDS AND YELLOW ENCAPSULATION. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE WAS WITHIN SPECIFICATION. CLOUDY AFTER AUTOCLAVE DISINFECTION PROCESS IN THE GEL. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED GRADE IV CAPSULAR CONTRACTURE. LEFT SIDE. DEVICE EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. PHOTO ANALYSIS EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: WHITE TISSUE, WHITE PARTICLE MATERIAL ON THE SHELL. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 IV.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED GRADE IV CAPSULAR CONTRACTURE. LEFT SIDE. DEVICE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022835 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2900844

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention