BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMAX

    MDR report key: 3942120 · Received July 17, 2014

    Report

    Report Number
    1643264-2014-00014
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 25, 2014
    Manufacturer
    OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. HOWEVER, REVIEW OF THE IFU SHOWS THAT THIS DEVICE WAS MANUFACTURED WITH SOME TYPE OF PAD. (B)(4).

    Description of Event or Problem · 1

    THREE PATIENTS REPORTED THE SAME COMPLAINTS TO THE HOSPITAL (B)(6). AFTER ARTHROSCOPIC ROTATOR CUFF REPAIR OPERATIONS USING T-MAX, THE PATIENTS EXPERIENCED SWELLING ON THEIR BACK AND HIP. THE PATIENTS CPK LEVELS WERE APPROXIMATELY 10000 ~ 15000. AFTER THE INCIDENT, SNEKK SALES REP INSTRUCTED THE USER FACILITY TO PLACE A CUSHION MATERIAL BETWEEN THE PATIENT AND THE DEVICE. THE PATIENTS WERE INSERTED AN INTRAVENOUS DRIP FOR 3 OR 4 DAYS WITH CAREFUL ATTENTION TO CPK. WE HAVE NOT RECEIVED ANY OTHER INTERVENTION INFORMATION ASIDE FROM THE INTRAVENOUS DRIP. THE SWELLING WAS NOTICED AFTER THE PROCEDURES WERE COMPLETED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418497 TMAX T-MAX, ESCHMANN/JAP, TABLES FWZ OKLAHOMA CITY MANUFACTURING SITE 72200481

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R