BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3843620 · Received May 23, 2014

    Report

    Report Number
    1222780-2014-00079
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 23, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURER DATE IS NOT KNOWN. DEVICE HISTORY AND STERILE LOT RECORDS WERE UNABLE TO BE REVIEWED AS PRODUCT IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION (EXACT DATE UNK). THE PT EXPERIENCED "PELVIC PAIN" AFTER THE PROCEDURE. THE PHYSICIAN "NOTED A PELVIC ABSCESS WHICH WAS DRAINED AND THE PT WAS SENT HOME". ON (B)(6) 2014, IT WAS FURTHER REPORTED THE PT "HAD PELVIC PAIN AND WAS ADMITTED TO THE EMERGENCY ROOM (ER). NO BOWEL INJURY NOTED, BUT SHE DID HAVE A PELVIC ABSCESS THAT WAS DRAINED AND TREATED WITH ANTIBIOTICS". THE PHYSICIAN DID NOT SUSPECT ANY PERFORATIONS. THE PT DID WELL AND WAS DISCHARGED. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFO SURROUNDING THIS EVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309059 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNK