MalfunctionJCX
SU100DC
Received Nov 1, 2024
Report 3003188183-2024-90001 · MDR key 20585207
Device
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE AS MDR NO. 3006446479-2023-00001. MDR REPORT CONTENTS: THE PATIENT REPORTED ONE UNIT OF SU100DC THAT STARTED SMOKING WHILE USING THE UNIT. NO REPORT OF INJURY WAS RECEIVED. EVIDENCE SHOWS THAT THE UNIT BURNT OUT. NG Q'TY: (B)(4).