BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19163964 · Received April 23, 2024

    Report

    Report Number
    9617229-2024-06984
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    February 21, 2023
    Report Date
    August 23, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191606752
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE AND RUPTURE WAS RECEIVED ON (B)(6) 2024, WITH LOT NUMBER 2012569. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. RUPTURE: NOT OBSERVED OPENINGS DURING THE ANALYSIS. AS PER THE INVESTIGATION PROCEDURES CREASES, WEAR ABRASION, PARTICLES AND DEFORMATION WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    PATIENT REPORTED LEFT SIDE SUSPECTED DEVICE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE SUSPECTED DEVICE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328577 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI 05060191606752

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention