FDA Adverse Event
Other
Summary report: N
*
MDR report key: 980466
·
Received December 21, 2007
Report
- Report Number
- 8040864-2007-00001
- Event Type
- Other
- Date Received
- December 21, 2007
- Manufacturer
- PURNABINA SDN BHD
- Product Code
- LYY
- PMA / PMN Number
- K003904
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT INFO AND SAMPLES SENT TO MFG PLANT. RESULTS OF THE INVESTIGATION ARE EXPECTED AND FINDINGS WILL BE ISSUED IN A FOLLOW-UP REPORT. IMMEDIATE ACTION: THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO INCONSISTENCY IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | LYY | PURNABINA SDN BHD | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |