BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17312464 · Received July 12, 2023

    Report

    Report Number
    9617229-2023-11167
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 12, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: KIM, HYUNG BAE MD; HAN, HYUN HO MD, PHD; EOM, JIN SUP MD, PHD. MAGNETIC RESONANCE IMAGING SURVEILLANCE STUDY OF SILICONE IMPLANT-BASED BREAST RECONSTRUCTION: A RETROSPECTIVE OBSERVATIONAL STUDY. PLASTIC & RECONSTRUCTIVE SURGERY-GLOBAL OPEN 11(6):P E5031, JUNE 2023. DOI: 10.1097/GOX.0000000000005031. 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

    THROUGH JOURNAL ARTICLE "MAGNETIC RESONANCE IMAGING SURVEILLANCE STUDY OF SILICONE IMPLANT-BASED BREAST RECONSTRUCTION: A RETROSPECTIVE OBSERVATIONAL STUDY¿. HEALTHCARE PROFESSIONAL REPORTED THAT "SIX PATIENTS WERE ALSO EXCLUDED BECAUSE THEY WERE ALREADY DIAGNOSED WITH RUPTURES IN ANOTHER IMAGING STUDY" AGAINST UNKNOWN SIDES. DEVICE STATUSES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803207 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention