OtherNRB
MIST THERAPY SYSTEM
Received Apr 21, 2009 · Event occurred Mar 6, 2009
Report 3004580659-2009-00002 · MDR key 1369278
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Electric Shock
Narrative
Additional Manufacturer Narrative
COMPANY REPRESENTATIVE REVIEWED PROPER USE OF THE DEVICE AND ADHERENCE TO THE IFU WITH INDIVIDUAL INVOLVED IN THIS REPORT AS FOLLOW-UP TO THE INCIDENT.
Description of Event or Problem
TREATMENT NURSE STATED SHE RECEIVED A SHOCK FROM THE TRANSDUCER WAND DURING A PATIENT TREATMENT. NURSE DESCRIBED THE SHOCK AS "AN INTENSE SENSATION" WHEN SHE TOUCHED THE TRANSDUCER TIP, AND FELT THE SENSATION ONLY AT THE POINT OF THE INJURY.