FDA Adverse Event
Other
Summary report: N
MIST THERAPY SYSTEM
MDR report key: 1321295
·
Received February 4, 2009
Report
- Report Number
- 3004580659-2009-00001
- Event Type
- Other
- Date Received
- February 4, 2009
- Date of Event
- January 5, 2009
- Report Date
- February 3, 2009
- Manufacturer
- CELLERATION, INC.
- Product Code
- NRB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TREATMENT NURSE WAS SITTING ON THE FLOOR TREATING A PT WITH A FOOT INJURY. THE DEVICE TRANSDUCER WAND WAS IN HER RIGHT HAND AND SHE PLACED HER LEFT HAND IN FRONT OF THE TRANSDUCER TO CHECK FOR A MIST. SHE CLAIMS THAT SHE DID NOT TOUCH THE TIP, BUT FELT A SHOCK AND THE PAIN TRAVELED UP HER ARM. AFTER TREATMENT, SHE REMOVED HER GLOVE AND THE INJURY CAUSED A BLISTER. SHE NOTICE THAT THE GLOVE HAD 2 PIN HOLES IN IT. THE INJURY CAUSED PAIN TO THE AREA FOR A DAY BUT IS HEALING.
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 |