FDA Adverse Event
Other
Summary report: N
MIST THERAPY SYSTEM
MDR report key: 1369278
·
Received April 21, 2009
Report
- Report Number
- 3004580659-2009-00002
- Event Type
- Other
- Date Received
- April 21, 2009
- Date of Event
- March 6, 2009
- Report Date
- April 20, 2009
- Manufacturer
- CELLERATION, INC.
- Product Code
- NRB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
COMPANY REPRESENTATIVE REVIEWED PROPER USE OF THE DEVICE AND ADHERENCE TO THE IFU WITH INDIVIDUAL INVOLVED IN THIS REPORT AS FOLLOW-UP TO THE INCIDENT.
Description of Event or Problem · 1
TREATMENT NURSE STATED SHE RECEIVED A SHOCK FROM THE TRANSDUCER WAND DURING A PATIENT TREATMENT. NURSE DESCRIBED THE SHOCK AS "AN INTENSE SENSATION" WHEN SHE TOUCHED THE TRANSDUCER TIP, AND FELT THE SENSATION ONLY AT THE POINT OF THE INJURY.
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 |