CALMING HEAT FLEXI WRAP
Received Mar 18, 2026 · Event occurred Apr 1, 2023
Report 3003799587-2026-00009 · MDR key 24627428
Device
Generic name
Heating Pad Powered
Manufacturer
Zhejiang Lumeng Health & Technology Co.Product problems
- Improper or Incorrect Procedure or Method
Patient
NA · Female
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
THIS REPORT WAS RECEIVED ON 16-JUN-2023 REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH THE CALMING HEAT FLEXI WRAP. ON AN UNSPECIFIED DATE IN (B)(6) 2023, THE CONSUMER USED THE CALMING HEAT FLEXI WRAP WITH ALL FUNCTIONS IN USE WITH THE MASSAGE AND HEAT SETTINGS FOR THIRTY TO SIXTY MINUTES. WHILE USING THE PRODUCT, SHE DID NOT FEEL ANY BURNING. WHEN SHE REMOVED THE HEAT WRAP, HER SKIN WAS RED. THE NEXT DAY IT WAS BLISTERED. SHE WENT TO URGENT CARE AND WAS DIAGNOSED WITH A FIRST DEGREE BURN. SHE WAS ADVISED TO USE NEOSPORIN. AT THE TIME OF THE REPORT, SHE HAD SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THERE IS AN INSTRUCTION THAT STATES: "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" - CONSUMER FAILED TO PERFORM THAT INSTRUCTION.