N
Patient 1
FOREIGN ZIP CODE: (B)(6).
MAUDE MDR 8512579
- MDR report key
- 8512579
- Report number
- 3006524618-2019-00183
- Event key
- 0
- Event type
- 3
- Date received
- 2019-04-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JIM GONZALES
- Address
- 7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
- Phone
- 512-512-5123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | BALLOON, EPISTAXIS | ARTHROCARE CORP. | EMX | UNKNOWN | UNKNOWN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-14 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING PROCEDURE, THE BLUE SHEATH OF RAPID RHINO WAS NOT REMOVED PRIOR TO INSERTION, PRODUCING SEPTAL ABRASION AND EXACERBATION OF EPISTAXIS IN THE PATIENT. IT IS UNKNOWN THE QUANTITY OF BLOOD THE PATIENT HAVE LOST. THE PATIENT OUTCOME IS UNKNOWN.