FDA Adverse Event
Other
Summary report: N
SYNCHROMED EL
MDR report key: 505851
·
Received December 16, 2003
Report
- Report Number
- 6000030-2003-01176
- Event Type
- Other
- Date Received
- December 16, 2003
- Report Date
- November 3, 2003
- Manufacturer
- RICE CREEK MFR
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MFR | 862718 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Other | CATHETER MODEL 8711 LOT# J11155R37 IMPLANTED: 2002| EXPLANTED: UNK. |