BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 15303576 · Received August 26, 2022

    Report

    Report Number
    1645337-2022-09795
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001232
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. LOT 163400 PROVIDED BY THE CUSTOMER DOES NOT CORRESPOND TO A FINISHED DEVICE, AND WE ARE THEREFORE UNABLE TO PERFORM A MANUFACTURING RECORD EVALUATION. FOLLOW UPS ARE BEING PERFORMED FOR MORE INFORMATION, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF INFORMATION. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN D6B EXPLANTATION DATE: (B)(6) 2022. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN ON HER LEFT SIDE POSTOPERATIVELY. MAMMOGRAM WAS TAKEN. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088773 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501640 163400 00081317001232

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other