N
Patient 1
DEVICE NOT RETURNED.
MAUDE MDR 5922305
- MDR report key
- 5922305
- Report number
- 1038445-2016-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-08-02
- Date received
- 2016-09-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. MATTHEW PRICE
- Address
- 100 CENTURION WAY WILLIAMSTON MI 48895 US
- Phone
- 517-517-5175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CENTURION INTROFLEX | INTRAVASCULAR CATHETER, PRODUCT CODE: OES | CENTURION MEDICAL PRODUCTS | OES | ECVC1915 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-01 | 0 | 1. R |
Event Narratives#
D
Patient 1
INTRODUCER SIDE PORT TUBE SEPARATED FROM THE HUB.