FDA Adverse Event
Other
Summary report: N
MIST THERAPY SYSTEM
MDR report key: 988826
·
Received January 25, 2008
Report
- Report Number
- 3004580659-2008-00001
- Event Type
- Other
- Date Received
- January 25, 2008
- Date of Event
- December 3, 2007
- Report Date
- January 25, 2008
- Manufacturer
- CELLERATION, INC.
- Product Code
- NRB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS DELAYED DUE TO SALES REP NOT COMMUNICATING WITH THE MANUFACTURER'S COMPLAINT COORDINATOR IN A TIMELY FASHION. REVIEW OF REPORTING TIME FRAMES WAS DONE WITH SALES REP.
Description of Event or Problem · 1
PHYSICAL THERAPIST TOUCHED THE TIP OF THE TRANSDUCER INTENTIONALLY, WHEN SHE NOTICED THAT THERE WAS NO SALINE COMING OUT OF THE APPLICATOR. SHE RECEIVED A FRICTION BURN TO HER FINGERTIP, BUT HAS HAD NO COMPLICATIONS AS A RESULT OF THE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIST THERAPY SYSTEM | NONE | NRB | CELLERATION, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |