BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 183893 · Received August 21, 1998

    Report

    Report Number
    183893
    Event Type
    Other
    Date Received
    August 21, 1998
    Date of Event
    August 12, 1998
    Report Date
    August 20, 1998
    Manufacturer
    NA
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL CAPSULAR CONTRACTURE WHICH REQUIRED BILATERAL CAPSULECTOMY AND REMOVAL AND REPLACEMENT OF BILATERAL BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant SALINE BREAST IMPLANT FWM NA UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other