InjuryIPF
VECTRA GENISYS 2CH COMBO
Received Jun 19, 2009 · Event occurred Feb 12, 2009
Report 1022819-2009-00145 · MDR key 1404758
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Blister(s)
- Skin Discoloration
Narrative
Description of Event or Problem
INTERFERENTIAL CURRENT TREATMENT WAS ADMINISTERED TO LOW BACK USING FOUR 2 INCH ROUND ELECTRODES IN CRIS CROSS PATTERN. TREATMENT WAS SET FOR 20 MINUTES AT STANDARD IFC SETTINGS. INTENSITY WAS ADJUSTED TO 35 VOLTS AND THEN INCREASED TO 40 VOLTS WITH REPORTED COMFORT. THE SKIN WAS CHECKED AT 5 MINUTE INTERVALS AND AFTER 10 MINUTES OF TREATMENT, BROWN HARDEN AREAS WERE NOTED UNDER THE ELECTRODES. BLISTERING OF THE DISCOLORED AREAS SOME TIME LATER.
Additional Manufacturer Narrative
AWAITING RETURN AND EVALUATION OF THE DEVICE. INVESTIGATION FINDINGS WILL BE PROVIDED UPON DEVICE EVALUATION CONCLUSION.