InjuryISA
CERAGEM-RH
Received Feb 5, 2009 · Event occurred Feb 3, 2009
Report MW5009886 · MDR key 1307447
Device
Generic name
Automatic Thermal Massager
Manufacturer
UnknownProduct problems
- Unknown (for use when the device problem is not known)
Patient
62 YR
- Burn, Thermal
Narrative
Description of Event or Problem
I WAS BURNED BY A CERAGEM-RH AUTOMATIC THERMAL MASSAGER. THIS IS SUPPOSED TO BE AN FDA 510-K- CLASS II MEDICAL DEVICE. THIS BURNS ARE NOT DISABILITATING NOR WILL THEY CAUSE PERMANENT DAMAGE BUT AFTER TALKING TO THE CORPORATE OFFICE AND THE OWNER OF THE LOCATION WHERE I WAS BURNED, IT SEEMS THAT THE DEVICE IS WORKING AS DESIGNED AND THEY DON'T KNOW WHY I WAS BURNED. SINCE THEY MAKE A BIG DEAL ABOUT BEING FDA APPROVED, I THOUGHT YOU SHOULD KNOW THAT THE MACHINES ARE NOT SAFE. DOSE: 40 MINUTES SESSION. DATES OF USE: 40 MINUTES, 2009. DIAGNOSIS: RELAXATION ONLY.