SUNBEAM
Received Dec 2, 2022
Report 3010805625-2022-00046 · MDR key 15905716
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
CONSUMER ALLEGES SHE WAS LAYING AGAINST THE HEATING PAD AND RECEIVED A BURN ON HER BACK. 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. THERE IS AN INSTRUCTION THAT STATES, "DO NOT SIT ON, AGAINST, OR CRUSH PAD-AVOID SHARP FOLDS" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.
Description of Event or Problem
CONSUMER ALLEGES SHE WAS LAYING AGAINST THE HEATING PAD AND RECEIVED A BURN ON HER BACK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.
Additional Manufacturer Narrative
CONSUMER DISCARDED ORIGINAL/CLAIM UNIT. CONSUMER RETURNED REPLACEMENT HEATING PAD ONLY. REVIEW/EXAMINATION PERFORMED ON REPLACEMENT UNIT ONLY. 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. THERE IS AN INSTRUCTION THAT STATES, "DO NOT SIT ON, AGAINST, OR CRUSH PAD-AVOID SHARP FOLDS" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.