BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14286316 · Received May 5, 2022

    Report

    Report Number
    9617229-2022-07074
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 14, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607520
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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.

    Additional Manufacturer Narrative · 0

    PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED. LOT NUMBER IN THE PATCH: 3142262. OBSERVED BROKEN DEVICE. OBSERVED RED PARTICLES. 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED, BROKEN DEVICE ON POSTERIOR SIDE ASSESSED AS UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WITHIN SPECIFICATION). ADDITIONAL OBSERVATIONS: CREASE IS OBSERVED. WEAR ABRASION IS OBSERVED. MISSING SHELL ASSESSED AS INCONCLUSIVE. BLACK PARTICLES WERE OBSERVED ON THE SHELL.

    Description of Event or Problem · 0

    PHYSICIAN REPORTS RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTS RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTS RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459522 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3142262 05060191607520

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention