BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 481889 · Received September 5, 2003

    Report

    Report Number
    2210968-2003-00342
    Event Type
    Injury
    Date Received
    September 5, 2003
    Date of Event
    January 1, 1999
    Report Date
    August 8, 2003
    Manufacturer
    GYNECARE, INC.
    Product Code
    MKN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A D&C, THAN A BALLOON ABLATION PROCEDURE DURING 1999. LATER THAT EVENING, THE PT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE PAIN AND WAS HEMORRHAGING. THE PT RECEIVED 2 UNITS OF BLOOD. A HYSTERECTOMY WAS PERFORMED THE NEXT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER I MKN GYNECARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention