InjuryLOF
PEMF - PHYSIOSTIM
Received Apr 9, 2026 · Event occurred Mar 11, 2026
Report 2183449-2026-00008 · MDR key 24830501
Device
Generic name
Bone Growth Stimulator, Physiostim
Manufacturer
Orthofix, LlcModel number
5302Catalog number
655302-0001
Product problems
- Insufficient Device Problem Information
Patient
50 YR · Male
- Blister
- Swelling/ Edema
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SWELLING ON THE BACK OF THE FOOT THAT IS CAUSING BLISTERS AND BLEEDING.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR INVESTIGATION. AS RECEIVED, DEVICE WAS ABLE TO POWER ON AND CHARGING AND PASS POST. DEVICE COMPLETED 3HRS TREATMENT OF HEATING TEST. NO DAMAGE NOTED TO SYSTEM. SYSTEM OPERATES AS DESIGNED. DHR WAS REVIEWED DURING THE INVESTIGATION AND ALL UNITS FROM THE WORK ORDER PASSED INSPECTION.