D
Patient 1
A PULLBACK WAS PERFORMED AND THE IMAGES WERE DARK AND NOT SHARP ON THE SYSTEM. THE PROCEDURE WAS NOT COMPLETED.
MAUDE MDR 8745496
- MDR report key
- 8745496
- Report number
- 3009600098-2019-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-05-20
- Date received
- 2019-06-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- STEPHANIE O' SULLIVAN
- Address
- 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US
- Phone
- 651-651-6517
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FRU M5 ENGINE R RFB | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | ST. JUDE MEDICAL CATD | NQQ | 100122796 | 4793417 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-06-28 | 0 | 1. O |