MAUDE MDR 9823883
- MDR report key
- 9823883
- Report number
- 9610877-2020-00058
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. WILLIAM GOELLER (TEMPORARY)
- Address
- 3 PARAGON DRIVE MONTVALE, NJ US
- Phone
- 431-431-4315
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PENTAX | VIDEO DUODENOSCOPE | HOYA CORPORATION PENTAX TOKYO OFFICE | FDT | ED-3490TK | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-12 | 0 |
Event Narratives#
No narrative records found.