D
Patient 1
ADD'L INFO RECEIVED FROM MFR ON 11/19/99: THIS PRODUCT IS NOT MFG BY CLASSIC MEDICAL, INC. CO HAS FORWARDED ALL CORRESPONDENCE TO THE MFR, AND IS INFORMED THEY WILL RESPOND DIRECTLY.
MAUDE MDR 244342
- MDR report key
- 244342
- Report number
- MW4002617
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-09-13
- Date received
- 1999-09-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 0
- Event location
- 3
Related Records
Manufacturer Contact
- Report source
- P
- Manufacturer link flag
- N
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UROPATCH | BOVINE PERICARDIAL GRAFT | CLASSIC MEDICAL INC. | MFX | * | * | * | N | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1999-09-29 | 0 |
Event Narratives
Related GUDID Devices By Product Code
No records found.