BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR

    MDR report key: 1933933 · Received December 16, 2010

    Report

    Report Number
    MW5018631
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT SUSTAINED BURNS WITH BLISTERING TO HER VAGINA. DEVICE IS USED TO TREAT EXCESSIVE MENSTRUAL BLEEDING BY INSTILLING HEATED SALINE INTO THE UTERINE CAVITY. IT IS BELIEVED THAT SOME OF THE HOT FLUID LEAKED INTO THE VAGINA (FROM THE UTERUS) CAUSING THE BURNS. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: EXCESSIVE MENSTRUAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR HTA MNB BOSTON SCIENTIFIC M006560000 40664

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other