InjuryIRT
SUNBEAM
Received Apr 10, 2025 · Event occurred Mar 4, 2025
Report 3007790958-2025-00017 · MDR key 21814623
Device
Product problems
- Labelling, Instructions for Use or Training Problem
- Labelling, Instructions for Use or Training Problem
Patient
NA · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
AN CLAIMS MANAGEMENT SERVICES OFFICE IS FILING A LETTER NOTICE UNDER CASE REFERENCE NUMBER (B)(4) ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO ITS CLIENT'S BODY. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.
Additional Manufacturer Narrative
THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.