CMF
Received Jun 17, 2026 · Event occurred May 19, 2026
Report 9616086-2026-00024 · MDR key 25538355
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR · Male
- Burn(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT 56-YEAR-OLD MALE PRESENTS TO URGENT CARE WITH A OPEN SORE ON HIS LEFT FOOT A T WEEK AFTER HE USED HIS STIMULATOR ON THE AREA. PATIENT WAS SEEING WOUND CENTER FOR AN OPEN SORE IN THE AREA BUT WAS DISCHARGED RECENTLY. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE CONFIRMED ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF MORE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT 56-YEAR-OLD MALE PRESENTS TO URGENT CARE WITH A OPEN SORE ON HIS LEFT FOOT A T WEEK AFTER HE USED HIS STIMULATOR ON THE AREA. PATIENT WAS SEEING WOUND CENTER FOR AN OPEN SORE IN THE AREA BUT WAS DISCHARGED RECENTLY.