BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8972261 · Received September 6, 2019

    Report

    Report Number
    9617229-2019-12628
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    July 22, 2019
    Report Date
    October 26, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607308
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON SEPTEMBER 15, 2022, WITH LOT NUMBER: 3130958. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: DEFORMATION DEVICE OBSERVED ON THE DEVICE. YELLOW PARTICLES ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 0

    ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "PATIENT HAS EXPERIENCED CAPSULAR CONTRACTURE IN THE RIGHT SIDE BREAST, ACCORDING TO THE CLINICAL EXAM IT IS RELATED TO GRADE 3" AND "PATIENT TAKES DRUGS FOR PAIN RELIEF." THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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 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 III THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "PATIENT HAS EXPERIENCED CAPSULAR CONTRACTURE IN THE RIGHT SIDE BREAST, ACCORDING TO THE CLINICAL EXAM IT IS RELATED TO GRADE 3" AND "PATIENT TAKES DRUGS FOR PAIN RELIEF." THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765889 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3130958 05060191607308

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention