BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE SURESOUND

    MDR report key: 17804076 · Received September 22, 2023

    Report

    Report Number
    1222780-2023-00356
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 22, 2023
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21. CFR PART 803. THE SUBMISSION IS BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONFIRMATION OF DEVICE MALFUNCTION INVOLVING THE HOLOGIC PRODUCTS IN THE EVENT DESCRIBED. DEVICE IDENTIFIER : (B)(4). D4: LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. H3: THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2023 , HOLOGIC RECEIVED INFORMATION FROM A PATIENT´S HUSBAND IN WHICH HE REPORTED THAT ¨THE DEVICE MESSED UP MY WIFE¨. HOLOGIC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER WITHOUT RESPONSE. AS OF 09/22/2023 NO ADDITIONAL INFORMATION REGARDING THE EVENT NOR THE PRODUCT. HOLOGIC WILL SUBMIT A REPORT IN AN ABUNDANCE OF CAUTION AND WILL CONTINUE ATTEMPTS TO OBTAIN FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266764 NOVASURE SURESOUND DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC 2007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other