BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 214228 · Received March 11, 1999

    Report

    Report Number
    214228
    Event Type
    Other
    Date Received
    March 11, 1999
    Date of Event
    February 25, 1999
    Report Date
    March 10, 1999
    Manufacturer
    UNK
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD PREVIOUSLY UNDERGONE BILATERAL MASTECTOMIES WITH IMPLANTS. THE PT PRESENTED AFTER BEING INVOLVED IN A MOTORCYCLE-TRAILER ACCIDENT IN SEPTEMBER 1998 WHERE SHE SUSTAINED PNEUMOTHORAUS & 5 BROKEN RIBS. SINCE THE TIME OF INJURY, PT NOTICED FLATTENING & INDENTATION ON THE RIGHT SIDE. CLINICAL EXAMINATION HAS SHOWN SIGNIFICANT BILATERAL CONTRACTURES ALSO. REPLACEMENT SURGERY WAS REQUESTED BY THE PT AND PERFORMED ON 2/25/1999. BOTH RIGHT AND LEFT SIDES REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other