MAUDE MDR 8732971
- MDR report key
- 8732971
- Report number
- 3006897778-2019-00010
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-05-29
- Date received
- 2019-06-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | ESOFLIP | ESOPHAGEAL DILATOR WITH BALLOON AND ELECTRODE SENSORS | CROSPON LTD | PIE | ES-330 | ES-330 | | | | | *
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-06-25 | 0 | 1. H; 2. R
|
Event Narratives#
No narrative records found.