BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLWAVE

    MDR report key: 8197830 · Received December 26, 2018

    Report

    Report Number
    2133936-2018-00001
    Event Type
    Injury
    Date Received
    December 26, 2018
    Report Date
    December 14, 2018
    Manufacturer
    UROLOGIX, LLC
    Product Code
    MEQ
    UDI-DI
    M876PT10360
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON 23AUG2018 WE WERE CONTACTED BY CLINICIAN FROM (B)(6) MEDICAL ((B)(6) AREA, (B)(6)) ABOUT A COOLWAVE MACHINE IN NEED OF PREVENTATIVE MAINTENANCE. THE REQUEST STEMMED FROM A REPORT OF A CTT PATIENT DEVELOPING A RECTAL FISTULA POST PROCEDURE. PROCEDURE DATE IS CURRENTLY UNK. FIRST REPORT OF THE FISTULA IS CURRENTLY UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036590 COOLWAVE CTT MEQ UROLOGIX, LLC PT1036 M876PT10360

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability