FDA Adverse Event
Other
Summary report: N
SPECIAL PCI II 7F
MDR report key: 2753774
·
Received September 7, 2012
Report
- Report Number
- 1625425-2012-00085
- Event Type
- Other
- Date Received
- September 7, 2012
- Report Date
- September 7, 2012
- Manufacturer
- ARGON MEDICAL DEVICES INC.
- Product Code
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN-PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE EVALUATION IS COMPLETE.
Description of Event or Problem · 1
DAMAGED PACKAGE. THE TRAY HAS BEEN MELTED AND THE HOLE WAS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECIAL PCI II 7F | NONE | NA | ARGON MEDICAL DEVICES INC. | NA | 11015265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |