OtherIPF
ZYNEX
Received Jul 12, 2011 · Event occurred Jun 14, 2011
Report 1723686-2011-00005 · MDR key 2181504
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn(s)
Narrative
Additional Manufacturer Narrative
CONCLUSION: COULD NOT DUPLICATE THE PROBLEM SEEN BY THE CUSTOMER, LIKELY THE INCREASED STIM WAS DUE TO THE MODE IT WAS IN.
Description of Event or Problem
PT REPORTED THAT SHE HAS A BURN ON THE BACK OF HER NECK USING THE TENS DEVICE.
Remedial action
- Repair