BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR 350-1640

    MDR report key: 177607 · Received July 17, 1998

    Report

    Report Number
    177607
    Event Type
    Injury
    Date Received
    July 17, 1998
    Date of Event
    June 23, 1998
    Report Date
    July 14, 1998
    Manufacturer
    MENTOR H/S
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL BREAST IMPLANTS 7/15/1997. IMPLANTS REMOVED 6/23/1998 FROM BOTH BREAST FOR LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR 350-1640 Implant BREAST IMPLANTS FWM MENTOR H/S R 350-1640, L 350-1640 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention