BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 13447577 · Received February 3, 2022

    Report

    Report Number
    9617229-2022-00953
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    January 11, 2022
    Report Date
    April 29, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: UNDERWEIGHT, BROKEN SHELL, AND MISSING SHELL (0-25%). A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: SHARP BROKEN WITH STRESS MARKS NEAR OF THE BROKEN SITE, THIS CONDITION WAS CALLED SURGICAL IMPACT. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: SHARP BROKEN ON POSTERIOR ASSESSED AS SURGICAL IMPACT. MISSING SHELL ASSESSED AS INCONCLUSIVE.

    Additional Manufacturer Narrative · 0

    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. PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED A BROKEN DEVICE, WITH LOT NUMBER 2231691 AND LABELED LEFT SIDE. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    PATIENT REPORTED A LEFT SIDE "TEXTURED PRODUCT" AND "RUPTURE." DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED A LEFT SIDE "TEXTURED PRODUCT" AND "RUPTURE." DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL CONFIRMED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530863 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2231691
    903064 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2231691

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention