FDA Adverse Event
Malfunction
Summary report: N
ANEURYSM CLIP
MDR report key: 2805653
·
Received October 16, 2012
Report
- Report Number
- 1045834-2012-00026
- Event Type
- Malfunction
- Date Received
- October 16, 2012
- Date of Event
- September 17, 2012
- Report Date
- September 18, 2012
- Manufacturer
- PETER LAZIC GMBH
- Product Code
- HCH
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS CURRENTLY ON HOLD PENDING AN INVESTIGATION.
Description of Event or Problem · 1
ANEURYSM CLIP CATALOG NUMBER 45.650 WAS LABELED AS 45.660.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANEURYSM CLIP | L-ANEURYSM CLIP | HCH | PETER LAZIC GMBH | L-ANEURYSM CLIP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |