PURERELIEF PRO FAR INFRARED XL HEATING PAD
Received Apr 15, 2025 · Event occurred Feb 9, 2025
Report 3011077581-2025-00001 · MDR key 21845149
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Male
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
CUSTOMER EMAILED BEAR DOWN BRANDS ON (B)(6) 2025 STATING: "I PURCHASED THIS HEATING PAD FROM AMAZON IN JAN OF 2023 I ONLY USE IT WHEN I NEED TO ON MY BACK PROBABLY 10 TIME IN DEC OF 2024 I USED IT ON MY BACK IN MY CHAIR AND FELL TO SLEEP AND IT DID NOT TURN OFF AND IT PUT 2ND AND THIRD DEGREE BURNS ON MY LOWER BACK I SPENT 3 TO 4 WEEK GOING TO THE BURN CENTER AT (B)(6) HEALTH."
Additional Manufacturer Narrative
CUSTOMER SERVICE LEFT VOICE MESSAGE ON (B)(6) 2025 TO REQUEST HEATING PAD BE RETURNED USING RETURN LABEL PROVIDED AND PROVIDE DETAILS ON MEDICAL VISITS. HISTORICAL DATA REVIEWED. THIS COMPLAINT IS THE ONLY COMPLAINT RECEIVED FOR PEFIR24-24 AND PEFIR24-SGT-RT (SAME BASE UNIT). BURN RATE (B)(4) FOR PEFIR24-IG, (B)(4) ALL PEFIR24 MODEL, WITHIN RISK ANALYSIS EXPECTATION. QC THIRD PARTY INSPECTION REPORTS REVIEWED; NO ISSUES FOUND.