FDA Adverse Event
Malfunction
Summary report: N
LASERS
MDR report key: 1570794
·
Received December 23, 2009
Report
- Report Number
- MW5014173
- Event Type
- Malfunction
- Date Received
- December 23, 2009
- Report Date
- December 23, 2009
- Manufacturer
- SPECTRANETICS CORP.
- Product Code
- MFA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
FAILURE TO PROVIDE INFORMATION AS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASERS | LASERS | MFA | SPECTRANETICS CORP. | LASERS | O |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |