FDA Adverse Event
Other
Summary report: N
MIST THERAPY SYSTEM
MDR report key: 726843
·
Received June 16, 2006
Report
- Report Number
- 3004580659-2006-00001
- Event Type
- Other
- Date Received
- June 16, 2006
- Date of Event
- April 24, 2006
- Report Date
- June 12, 2006
- Manufacturer
- CELLERATION, INC.
- Product Code
- NRB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DELAY IN FILING THIS REPORT DUE TO IT BEING THE FIRST FILED BY THE MANUFACTURER IN DEVICE HISTORY.
Description of Event or Problem · 1
EMPLOYEE AT HOSPITAL HAD EXPERIENCED AN INCIDENT WHER FINGERTIP TOUCHED THE TIP OF THE TRANSDUCER. THE INCIDENT WAS REPORTED DURING A SITE VISIT ON 4/24/2006 TO OUR SALES REPRESENTATIVE. THE EMPLOYEE WAS TRYING TO ADJUST THE APPLICATOR WHILE THE SYSTEM WAS TURNED ON, WHICH IS CONTRARY TO THE INSTRUCTIONS FOR USE. THE EMPLOYEE EXPERIENCED A "BURN AND SHOCK" ON THEIR FINGER. EMPLOYEE ACKNOWLEDGED THAT SHE SHOULD HAVE PAUSED THE SYSTEM PRIOR TO TRYING TO RE-SEAT THE APPLICATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIST THERAPY SYSTEM | * | NRB | CELLERATION, INC. | CP-80004 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |