CONAIR
Received Oct 15, 2025 · Event occurred Sep 15, 2025
Report 1222304-2025-00018 · MDR key 23304778
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
ON (B)(6) 2025 - THE CONSUMER CLAIMS SHE WAS BURNED WHILE IN USE OF THE DEVICE.
Additional Manufacturer Narrative
ON (B)(6) 2025 - WE HAVE BEEN IN CONTACT WITH THE CONSUMER TO IDENTIFY THE SEVERITY OF TIS ADVERSE EVENT. THE CONSUMER WILL BE RETURNING THE DEVICE TO THE MANUFACTURER FOR AN INVESTIGATION. 12/4/2025 - THE CONSUMER RETURNED THE DEVICE TO THE MANUFACTURER FOR AN INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED. BELOW IS THE MANUFACTURERS NARRATIVE: MANUFACTURERS NARRATIVE: DEVICE TESTING: THE UNIT WILL BE TESTED FOR ITS AUTO-OFF FEATURE AND ITS TEMPERATURE. BASED ON THE IB, THE UNIT'S MASSAGER WILL AUTO-OFF IN 20 MINS WHILE THE HEATER WILL TURN OFF IN 60 MINS. THE UNIT WILL BE OPERATED UNTIL THE MASSAGER TURNS OFF AND TIMED TO DETERMINE WHETHER IT AUTO-OFFS IN 20 MINS. THE UNIT WILL BE OPERATED UNTIL THE HEATER TURNS OFF AND TIMED TO DETERMINE WHETHER IT AUTO-OFFS IN 60 MINS. BASED ON THE UNIT'S EPS 4.2.3. SURFACE TEMPERATURE TEST, "THE MAXIMUM TEMPERATURE OF FABRIC SURFACE ABOVE THE HEATER WIRE SHOULD BE LESS THAN 80C, AND THE STABLE TEMPERATURE SHOULD BE 67 +- 8 C. THE MAXIMUM TEMPERATURE OF FABRIC SURFACE ABOVE THE MOTOR SHOULD BE LESS THAN 80C WITHIN 2 HOURS. OBSERVATIONS / RESULTS: UPON RUNNING THE UNIT FOR THE INITIAL AUTO-OFF TEST, IT WAS OBSERVED THAT ONLY ONE OF THE TWO MOTORS WERE OPERATIONAL. THE MASSAGER TURNED OFF IN 20 MINS, CONFIRMING THE CLAIM FROM THE IB. THE HEATER TURNED OFF IN 60 MINS, CONFIRMING THE CLAIM FROM THE IB. THE STABLE TEMPERATURE OF THE FABRIC SURFACE WAS 72C., PASSING THE PERFORMANCE REQUIREMENT OF ITS SPEC. THE MAXIMUM TEMPERATURE OF THE FABRIC SURFACE ABOVE THE MOTOR IS 43C, PASSING THE PERFORMANCE REQUIREMENT OF ITS SPEC. ROOT CAUSE: APART FROM ONE OF THE MOTORS NOT WORKING, THE REST OF THE UNIT OPERATES WITHIN ITS SPEC, COMPLYING WITH IB CLAIMS AS WELL AS PASSING PERFORMANCE REQUIREMENTS. THE IN OPERATION OF ONE OF THE TWO MOTORS WOULD NOT AFFECT THE PERFORMANCE OF THE HEATING PAD IN TERMS OF AUTO-OFF TIMING OR TEMPERATURE CHANGE. THERE IS NO INDICATOR THAT THIS WOULD CAUSE A BURN TO THE CONSUMER.
Additional Manufacturer Narrative
10/15/2025 - WE HAVE BEEN IN CONTACT WITH THE CONSUMER TO IDENTIFY THE SEVERITY OF TIS ADVERSE EVENT. THE CONSUMER WILL BE RETURNING THE DEVICE TO THE MANUFACTURER FOR AN INVESTIGATION.
Description of Event or Problem
ON (B)(6) 2025 - THE CONSUMER CLAIMS SHE WAS BURNED WHILE IN USE OF THE DEVICE.