inforMED
InjuryIRT

SOFTHEAT

Received Jan 29, 2025 · Event occurred Nov 4, 2025

Report 1314800-2025-00002 · MDR key 21270188

Device

Generic name

Heating Pad

Model number

HP215

Lot number

630GEM

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

NA · Female

  • Full thickness (Third Degree) Burn
  • Full thickness (Third Degree) Burn

Narrative

Description of Event or Problem

A CONSUMER STATED THAT SHE HAD RECEIVED A THIRD-DEGREE BURN ON HER LEFT HIP WHILE USING A HEATING PAD, AND MEDICAL ATTENTION WAS SOUGHT FOR HER INJURY. THE CONSUMER STATED AT THE TIME THE INJURY OCCURRED, SHE WAS USING THE HEATING PAD ON HER RIGHT HIP WHILE IN BED AND MUST HAVE TURNED OVER TO HER LEFT SIDE WHILE SHE WAS SLEEPING. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE, "DO NOT USE WHILE SLEEPING" AND "DANGER: IF USED IMPROPERLY, THIS PRODUCT CAN CAUSE SEVERE BURNS TO SKIN, AND DAMAGE TO PROPERTY" AND "THIS HEATING PAD IS INTENDED FOR USE ON TOP OF YOUR BODY. DO NOT SIT OR LIE ON TOP OF THE HEATING PAD. NEVER PLACE PAD BETWEEN YOURSELF AND CHAIR, SOFA, BED OR PILLOW." THIS HEATING PAD HAS BEEN DISCONTINUED AND IS NO LONGER BEING SOLD WITHIN THE US. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

Additional Manufacturer Narrative

KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.