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Getting Started Instructions for Downloading MedWatch Software

The Food and Drug Administration appreciates your submission of medical device adverse event reports. We hope the software you download from the FDA/CDRH World Wide Web Home Page is useful to you in this regard. If you have any questions concerning the use/operation of the software, contact the MedWatch Program Office at 1-800-FDA-1088 (Press 0) or 301-827-7240, or send a fax to 301-827-7241.

The information below should be of assistance in getting started using this software.

1. Getting Started.

Using the save to disk function of your Internet browser, download the executable file containing the MedWatch software (MWATCH.EXE) to a temporary directory on the C drive, e.g., C:\TEMP. At this point you can exit from your Internet browser. Go to the C:\TEMP directory by accessing the MS-DOS prompt on your PC. Windows® users may find this on the MAIN screen of the Program Manager.

• Once downloaded to the C: drive, execute the file by going to the C:\TEMP prompt and typing MWATCH and pressing the "enter" key. This will decompress the downloaded file and extract several files from it.
  • To get to the C:\TEMP prompt from within MS-DOS®, type CD \TEMP and press "enter".
• Next, type INSTALL from the C:\TEMP prompt, and press the "enter" key. Follow the instructions that appear on your screen.

This will cause the INSTALL.EXE program just extracted to configure the MedWatch program for your PC. INSTALL allows you to name the desired working directory; the default name is MEDWATCH but other names are possible. This will create the desired executable file (MW.EXE) in the named directory. After the install is complete, you will need to change directories to go to the location that the MedWatch software was installed. To do this follow the instructions below:

You should still be at the C:\TEMP prompt;

• type CD \MEDWATCH
  or
  
• type CD \ your_named_directory

and then execute the program by typing MW after the directory name prompt, i.e.,

• You should see one of the following prompts C:\MEDWATCH or C:\your_named_directory
  
  • from this prompt, type MW and press "enter"

For proper execution, you must be in the MEDWATCH (or your_named_directory) directory when executing this command.

2. General.

To initiate entry of a new report, choose the form desired, press the "enter" key, and then use the Case Report List screen. Select the Add option and press the "enter" key. Enter and save the minimal data requested. Press the "Esc" key to Save that data. The new entry will appear and be highlighted in the Case Report List. Press the "enter" key to obtain the MedWatch Form Menu Screen (MedWatch Sections A through H). Choose each needed MedWatch section; then enter, correct and save the data. When done, use the Case Report List Print option for a hardcopy.

For help on any screen please press the F1 key.

3. Questions Concerning Completing the 3500A.

Requests for guidance for completing the form for medical device incidents ONLY may be directed to the Center for Devices and Radiological Health at (301) 827-7537

4. MDR Materials.

Several healthcare and professional associations offer medical device related MDR materials free to their members or for a nominal charge. To obtain a list of these organizations through the CDRH Facts-on-Demand (FOD) system, call 800-899-0381 or 301-827-0111 from a touch-tone telephone. At the first voice prompt press 1 to access DSMA Facts, at second voice prompt press 2, and then enter the document number [4799] followed by the pound sign (#). Then follow the remaining voice prompts to complete your request.

To have the medical device "List of and Sources for MDR Related Documents" sent to your fax machine, call the CDRH FOD system following the instructions above, and enter the document number [799].

FDA/CDRH maintains an entry on the World Wide Web for easy access to information including text, graphics, and files that may be downloaded to a PC. Updated on a regular basis, the CDRH Home Page includes MDR Related Documents that have been issued by CDRH, including device safety alerts, Federal Register reprints, and other device oriented information. The documents are viewable with a pdf reader, and can be downloaded and printed. Information about a pdf reader is available.

Download MedWatch Software

(Y2K compatible)

Updated 2/29/00

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