BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUI SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16773195 · Received April 19, 2023

    Report

    Report Number
    9617229-2023-06970
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    August 1, 2022
    Report Date
    June 5, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191609111
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. TWO DEVICE REPORTED. UNKNOWN WHAT SIDE EACH DEVICE IS AND WHAT SIDE THE COMPLAINTS ARE FOR. SN (B)(6)/LOT 3052151/ CATALOG C-SHD-340. SN (B)(6)/LOT 3076172/CATALOG C-SHD-340.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "ANXIETY", "TENDERNESS, HURT", "WEAKNESS" (NON DEVICE RELATED), AND "PHYSICIAN RECOMMENDED AN ULTRASOUND TO CONFIRM A RUPTURE". THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED UNKNOWN SIDE "ANXIETY", "TENDERNESS, HURT", "WEAKNESS" (NON DEVICE RELATED), AND "PHYSICIAN RECOMMENDED AN ULTRASOUND TO CONFIRM A RUPTURE". THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685708 CUI SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3052151 05060191609111

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention