OtherISA
TOUCH N TONE MASSAGER WITH MAGNET ATTACHMENT
Received Jan 22, 2014 · Event occurred Aug 26, 2013
Report 1222304-2014-00003 · MDR key 3588188
Device
Product problems
- Overheating of Device
Patient
54 YR
- Burn(s)
Narrative
Description of Event or Problem
CONSUMER CLAIMS SHE WAS BURNED FROM THE CORD BEING DAMAGED AND ALSO SHE HAD THE UNIT OFF ON HER BED AND WHEN SHE ROLLED OVER SHE MUST HAVE HIT THE SWITCH AND IT TURNED ON, BURNING HER LEFT UPPER LEG.
Additional Manufacturer Narrative
IN TESTING NOW. WILL RESUBMIT TO FDA AND SEND UPDATED INFO AT A LATER DATE.
Remedial action
- Other