InjuryLOF
PEMF - PHYSIO STIM
Received Dec 19, 2025 · Event occurred Feb 22, 2023
Report 2183449-2025-00038 · MDR key 23855848
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR · Male
- Skin Discoloration
- Swelling/ Edema
- Skin Discoloration
- Swelling/ Edema
Narrative
Description of Event or Problem
PATIENT REPORTED THE DEVICE MADE HIS LEG(S) SWELL WITH PAIN IN THE LOWER LEG BY THE ANKLE. PATIENT REPORTED DISCOLORATION TO THE TOES AND SAID HIS PHYSICIAN ADVISED TO STOP USING THE DEVICE.
Additional Manufacturer Narrative
PATIENT REPORTED HE ENDED UP DOING SURGERY ON (B)(6) 2023 TO FIX HIS LEG AFTER DISCONTINUING USE OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE DEVICE IS NOT AVAILABLE FOR FURTHER INVESTIGATION.