BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14193943 · Received April 25, 2022

    Report

    Report Number
    9617229-2022-06461
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 15, 2021
    Report Date
    May 23, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607308
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PHONE NUMBER: (B)(6). (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS: CAPSULAR CONTRACTURE AND SEROMA 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: LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, "UNDULATIONS" AND SEROMA-LATE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE, SEROMA-LATE AND WRINKLING WAS REVIEWED ON MAY 19, 2022. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED AND LOT NUMBER 3031447, RED/WHITE ENCAPSULATION, RED PARTICLES MATERIAL ON THE SHELL AND DEFORMATION. 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

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, "UNDULATIONS" AND SEROMA-LATE TREATED THROUGH LEVOFLOXACIN AND DANZEN. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, "UNDULATIONS" AND SEROMA-LATE TREATED THROUGH LEVOLOXACIN AND DANZEN. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197182 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3031447 05060191607308

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention