BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1914876 · Received December 6, 2010

    Report

    Report Number
    3005099803-2010-04925
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER, THEREFORE, EXPIRATION AND MANUFACTURING DATES CANNOT BE DETERMINED. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT HAS BEEN DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE (PATIENT IDENTIFIER, AGE OR BIRTHDATE AND WEIGHT OF PATIENT ARE NOT KNOWN) ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTED THAT A BURN HAD BEEN SUSTAINED ON THE PATIENT'S RIGHT THIGH. CLINICAL FOLLOW UP INFORMATION REVEALED THAT THE BURN WAS SUSTAINED AS A RESULT OF TUBING LEFT ON THE THIGH, THE BURN WAS CATEGORIZED AS "2ND DEGREE", A TENACULUM WAS USED TO MAINTAIN A CERVICAL SEAL, THERE WERE NO ALARMS OR ERROR CODES, THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT'S ANATOMY, THE PATIENT WAS DILATED TO 7MM AND THE BURN WAS EXTERNAL ON THE INNER THIGH. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006560211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other