InjuryIRT
SUNBEAM
Received Feb 3, 2023 · Event occurred Oct 16, 2022
Report 3010805625-2023-00013 · MDR key 16290811
Device
Product problems
- Labelling, Instructions for Use or Training Problem
- Labelling, Instructions for Use or Training Problem
Patient
Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
AN ATTORNEY'S 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 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.