InjuryIPF
VECTRA GENISYS 2CH COMBO
Received Jun 19, 2009 · Event occurred May 14, 2009
Report 1022819-2009-00153 · MDR key 1406221
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT RECEIVED "VERY SMALL" BURN DURING ELECTROTHERAPY TREATMENT. TREATMENT PARAMETERS UNK.
Additional Manufacturer Narrative
A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATION.