BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15285138 · Received August 24, 2022

    Report

    Report Number
    9617229-2022-10005
    Event Type
    Injury
    Date Received
    August 24, 2022
    Report Date
    August 24, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191606738
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENTS OF SEROMA-LATE, AND CAPSULAR CONTRACTURE 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: SEROMA-LATE, AND CAPSULAR CONTRACTURE. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF INFLAMMATION/IRRITATION, PAIN, CAPSULAR CONTRACTURE, AND SEROMA-LATE, WAS RECEIVED ON AUG 01, 2022 WITH LOT NUMBER 2833656. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED, WEIGHT TO THE SPEC AND DEFORMATION. AFTER AUTOCLAVE CYCLE WERE OBSERVED: CLOUDY COLOR IN THE GEL AND VOIDS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    PATIENT REPORTED PAIN AGAINST LEFT DEVICE. "FIBROUS CAPSULE WITH CHRONIC NONSPECIFIC INFLAMMATION", MILD FLUID COLLECTION, AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN WAS LATER REPORTED. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323971 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2833656 05060191606738

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention