FDA Adverse Event
Other
Summary report: N
MIST THERAPY SYSTEM
MDR report key: 1264686
·
Received December 12, 2008
Report
- Report Number
- 3004580659-2008-00004
- Event Type
- Other
- Date Received
- December 12, 2008
- Date of Event
- December 4, 2008
- Report Date
- December 12, 2008
- Manufacturer
- CELLERATION, INC.
- Product Code
- NRB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
COMPANY REP RECEIVED ULTRASONIC BURN ON FINGER DURING DEMONSTRATION OF PRODUCT. USER HAD BEEN TRAINED ON PROPER USE OF THE DEVICE PRIOR TO THE BURN. BURN IS HEALING WITHOUT FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIST THERAPY SYSTEM | NONE | NRB | CELLERATION, INC. | CP-80004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |