InjuryIPF
ZYNEX
Received Jan 8, 2016 · Event occurred Jan 17, 2015
Report 1723686-2016-00003 · MDR key 5366369
Device
Generic name
Combo Electrical Stimulator
Manufacturer
Zynex Medical, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
UNIT WAS EVALUATED AND NO PROBLEMS WAS FOUND. MDR WASN'T REPORTED INITIALLY DUE TO FURTHER INVESTIGATION AND PHOTOS NOT BEING RECEIVED. PHOTOS ARE INCLUDED.
Description of Event or Problem
PATIENT REPORTED BURN MARKS ON HER UPPER ARM. SHE SAID SHE TOOK PICTURES AND WILL SEND TO US.
Remedial action
- Replace