FDA Adverse Event
Malfunction
Summary report: N
MIRA OS4081 TRANSILLUMINATING DIATHERMY HANDLE
MDR report key: 1735031
·
Received June 17, 2010
Report
- Report Number
- 1218813-2010-00006
- Event Type
- Malfunction
- Date Received
- June 17, 2010
- Manufacturer
- MIRA, INC.
- Product Code
- HQR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DIATHERMY HANDLE REMAINS ACTIVATED WITHOUT THE USER ACTIVATING THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRA OS4081 TRANSILLUMINATING DIATHERMY HANDLE | NONE | HQR | MIRA, INC. | OS4081 | HV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |