D
Patient 1
IT WAS STATED THAT VALVE IS NOT SEATING CORRECTLY CAUSING A BACK FLOW.
MAUDE MDR 125479
- MDR report key
- 125479
- Report number
- 2429473-1997-00094
- Event key
- 0
- Event type
- 3
- Date received
- 1997-10-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ONE-WAY MALE FLOW VALVE | ADAPTER | RUSCH, INC. | CBP | NA | 396798 | UNK | K925893 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1997-10-08 | 0 | 1. O |