inforMED
MalfunctionISA

DR SCHOLL'S BACK CUSHION MASSAGER

Received Jul 5, 2000 · Event occurred Jul 5, 2000

Report MW1019223 · MDR key 284619

Device

Generic name

Cushion Massager

Manufacturer

Helen Of Troy Lp

Model number

DR8550, A12-130P

Catalog number

*

Lot number

*

Product problems

  • Component(s), overheating of
  • Smoking

Patient

NA

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

SMOKE WAS COMING OUT OF HAND CONTROL WITH HEAT SETTING OFF. CUSHION WAS ON LOW SETTING. CUSHION WAS HOT TO TOUCH BUT HAD NO VISIBLE SIGNS OF BURNING. THERE WAS NO INJURY TO USER OR PROPERTY OTHER THAN CUSHION.