FDA Adverse Event
Malfunction
Summary report: N
SU100DC
MDR report key: 20585207
·
Received November 1, 2024
Report
- Report Number
- 3003188183-2024-90001
- Event Type
- Malfunction
- Date Received
- November 1, 2024
- Manufacturer
- VEGA TECHNOLOGIES INC.
- Product Code
- JCX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1930019 | SU100DC | ELECTRIC SUCTION UNITS | JCX | VEGA TECHNOLOGIES INC. | SU100DC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |