BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESOUND

    MDR report key: 2200786 · Received July 29, 2011

    Report

    Report Number
    1222780-2011-00137
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 30, 2011
    Manufacturer
    HOLOGIC
    Product Code
    HHM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURESOUND IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CAN NOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER OF THE SURESOUND. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. STERILE LOT RECORD WAS REVIEWED FOR THE SURESOUND DEVICE AND WERE CONFIRMED TO BE WITHIN SPECIFIED LIMITS. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH MANUFACTURER'S REPORT NUMBER 1222780-2011-00138. NINE DAYS FOLLOWING AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION (DONE ON (B)(6) 2011) THE PATIENT RETURNED WITH "FEVER AND ABDOMINAL PAIN". THE PATIENT HAD A HYSTERECTOMY ON (B)(6) 2011. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATHOLOGY REPORT INDICATED "CERVIX UNREMARKABLE. ENDOMETRIUM - SECRETORY WITH HEMORRHAGE AND INFLAMMATION AND WAS REMARKABLY RAGGED AND FRIABLE UPON EXAMINATION. MYOMETRIUM - SEROSAL HEMORRHAGE". ON (B)(6) 2011, THE NURSE REPORTED "THE PATIENT IS DOING WELL". WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESOUND HHM HOLOGIC NA 11A07B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other