OtherIPF
DEROYAL
Received May 29, 2012 · Event occurred Apr 24, 2012
Report 1060680-2012-00004 · MDR key 2595355
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn(s)
Narrative
Description of Event or Problem
THE END USER REPORTED THAT THE PT WAS BURNED DURING THE USER OF A DIGITAL TENS UNIT WITH FOUR ELECTRODES.
Additional Manufacturer Narrative
END USER: THE END USER REPORTED THAT THE PT WAS BURNED DURING THE USE OF A DIGITAL TENS UNIT WITH FOUR ELECTRODES. DEROYAL: THE DEFECTIVE SAMPLE WAS RETURNED. THE POWER BUTTON IS STUCK AND CONTINUES TO BE UNDER REVIEW.