BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    MDR report key: 841140 · Received April 20, 2007

    Report

    Report Number
    9710493-2007-00006
    Event Type
    Injury
    Date Received
    April 20, 2007
    Date of Event
    March 6, 2007
    Report Date
    April 20, 2007
    Manufacturer
    MICROSULIS MEDICAL LTD.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY ANALYZED THE MEA SYSTEM'S TREATMENT DATA FILE ASSOCIATED WITH THIS EVENT. THE CONCLUSIONS OF THE ANALYSIS WERE THAT BOTH THE APPLICATOR AND THE MEA SYSTEM WERE FUNCTIONING WITHIN OPERATING SPECIFICATIONS AT THE TIME OF THE TREATMENT, AND NO MALFUNCTIONS OR PERFORMANCE DEVIATIONS WERE PRESENT. THE COMPANY WILL FILE A FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES KNOWN. ADD'L CATALOG#: APPL. 900-002. ADD'L DEVICE MFR. DATE: APPL. 02/2005.

    Description of Event or Problem · 1

    PT WAS TREATED WITH A REUSABLE APPLICATOR WITHOUT INCIDENT. PT READMITTED TO HOSPITAL. ADDITIONAL SURGICAL PROCEDURES PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM MICROWAVE ENDOMETRIAL ABLATION DEVICE MNB MICROSULIS MEDICAL LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention