MalfunctionLOF
PEMF - PHYSIO-STIM
Received May 15, 2026 · Event occurred Apr 16, 2026
Report 2183449-2026-00023 · MDR key 25184366
Device
Generic name
Bone Growth Stimulator, Physiostim
Manufacturer
Orthofix, LlcModel number
655303-0001Catalog number
5303
Product problems
- Insufficient Device Problem Information
Patient
74 YR · Female
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE DEVICE RETURNED FOR INVESTIGATION BUT THE INVESTIGATION IS NOT COMPLETE. WHEN THE INVESTIGATION IS FINISHED A FOLLOW UP REPORT WILL BE SUBMITTED. A REVIEW OF THE DHR WAS PERFORMED AND ALL DEVICES PASSED FINAL INSPECTION.
Description of Event or Problem
IT WAS REPORTED THE DEVICE WAS GETTING HOT, MAKING THE PATIENTS SKIN FEEL HOT. PATIENT REPORTED IT FELT HOT WHEN IT WAS CHARGING.