BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE SURESOUND

    MDR report key: 11822875 · Received May 13, 2021

    Report

    Report Number
    1222780-2021-00099
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    December 3, 2020
    Report Date
    May 13, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. 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. THIS REPORT WAS SUBMITTED TO THE FDA UNDER REPORT: MDW 5100409.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT RECEIVED A NOVASURE PROCEDURE, ON THE FOLLOWING DAYS PATIENT EXPERIENCED SEVERE PAIN FOR WHICH SHE RECEIVED ADDITIONAL PAIN MEDICATION. ON (B)(6) 2021 PATIENT WAS SCHEDULED FOR A VAGINAL HYSTERECTOMY DUE TO THE PAIN. AFTER THE PROCEDURE PATIENT PERSISTED WITH PAIN AND TOOK ADDITIONAL PAIN MEDICATION AND ON (B)(6) 2021 PATIENT WAS HOSPITALIZED DUE TO SEVERE PAIN AND RECEIVED A CT SCAN WHICH REVEALED A LARGE ABSCESS, A MIDLINE WAS PLACED ON HER LEFT ARTERY TO ADMINISTRATE ANTIBIOTICS AND SHE WAS DISCHARGED ON (B)(6) 2021 WITH ANTIBIOTIC TREATMENT (AMPICILLIN EVERY 6 HOURS). ON (B)(6) 2021 A CT SCAN WAS PERFORMED REVEALING UTERINE FRAGMENTS FROM THE PREVIOUS SURGERY. ON (B)(6) 2021 A NEW CT SCAN WAS PERFORMED WITH CONTRAST WHICH FOUND STOOL BURDEN AND BLADDER WALL THICKENING. PATIENT UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS WITH REPAIR OF COLOTOMY, AND DURING THE PROCEDURE THEY FOUND UTERINE FRAGMENTS AND EXTENSIVE ADHESIONS WHICH WERE REMOVED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714588 NOVASURE SURESOUND DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. 2013

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R