FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 2195604
·
Received September 3, 2008
Report
- Report Number
- 2939204-2008-00352
- Event Type
- Malfunction
- Date Received
- September 3, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQX
- PMA / PMN Number
- K032146
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L PMA/510K #: K023700.
Description of Event or Problem · 1
MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | DQX | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |