FDA Adverse Event
Malfunction
Summary report: N
TRICUT
MDR report key: 2888327
·
Received December 27, 2012
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Report
- Report Number
- 2888327
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Date of Event
- December 12, 2012
- Report Date
- December 27, 2012
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- EQJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
THE INSTRUMENT DID NOT TRACK ON THE FUSION ENT WITH THE PATIENT SCAN. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRICUT | BUR, EAR, NOSE AND THROAT | EQJ | MEDTRONIC XOMED INC. | * | 0206315388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | NO OTHER THERAPIES |