FDA Adverse Event
Other
Summary report: N
MIST THERAPY SYSTEM
MDR report key: 1031761
·
Received April 15, 2008
Report
- Report Number
- 3004580659-2008-00002
- Event Type
- Other
- Date Received
- April 15, 2008
- Date of Event
- March 28, 2008
- Report Date
- April 15, 2008
- Manufacturer
- CELLERATION, INC.
- Product Code
- NRB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MFR'S EVAL OF SYSTEM INVOLVED IN REPORTED EVENT REVEALED SYSTEM OPERATING WITHIN TEMPERATURE SPECIFICATIONS. AN ATTEMPT WAS MADE TO DUPLICATE THE REPORT OF THE HORN BEING HOT ENOUGH TO BURN THROUGH A GLOVE, HOWEVER, THE MFR WAS UNABLE TO DO SO, AS THE HORN TIP DOES NOT REACH A TEMPERATURE SUFFICIENT TO BURN THROUGH A LATEX GLOVE WHEN THE ULTRASOUND IS OFF.
Description of Event or Problem · 1
NURSE CALLED TO REPORT OPERATIONAL ISSUE WITH MIST THERAPY SYSTEM, AND THAT SHE HAD TOUCHED THE END OF THE TRANSDUCER TO SEE IF THE HORN WAS BROKEN. SHE STATED THE TRANSDUCER WAS HOT, BURNED THROUGH HER GLOVE, AND BURNED HER FINGER, RESULTING IN A BLISTER. SEVERAL ATTEMPTS TO CONTACT THE REPORTER FOR ADD'L INFO ABOUT THE REPORTED EVENT HAVE BEEN UNSUCCESSFUL.
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 | UNK | Other |