BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16988959 · Received May 23, 2023

    Report

    Report Number
    9617229-2023-08601
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    April 12, 2023
    Report Date
    July 12, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607476
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE AND CREASE/FOLDING OF IMPLANT WAS RECEIVED ON (B)(6)2023, WITH LOT NUMBER 2864652. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED BROKEN ON POSTERIOR SIDE ASSESSED AS UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WITHIN SPECIFICATION) AND OBSERVED THREE OPENINGS ON RADIUS SIDE ASSESSED AS SURGICAL DAMAGE AND MISSING PIECE OF SHELL ASSESSED AS INCONCLUSIVE. CREASE/FOLDING OF IMPLANT: NO OBSERVED CREASES ON THE DEVICE. ADDITIONAL OBSERVATIONS: NO OTHER OBSERVATION OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 0

    CONTINUED H6 HEALTH EFFECT IMPACT CODE: F2203- IMAGING REQUIRED. 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. DEVICE PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. 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 INTRACAPSULAR RUPTURE OF THE RIGHT IMPLANT DIAGNOSED VIA MRI. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED INTRACAPSULAR RUPTURE OF THE RIGHT IMPLANT DIAGNOSED VIA MRI. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411213 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2864652 05060191607476

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention