D
Patient 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: DOCTOR ATTEMPTED TO USE THE CATHETER DURING A PROCEDURE, BUT WAS UNABLE TO BECAUSE THE LUMEN WAS CLOSED. PT CURRENT CONDITION IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
MAUDE MDR 2814503
- MDR report key
- 2814503
- Report number
- 8040412-2012-00174
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-10-09
- Date received
- 2012-10-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JASMINE BROWN
- Address
- PO BOX 12600 DURHAM NC 27709 US
- Phone
- 919-919-9193
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RUSCH SIMPLASTIC 3WAY 30CC 22F | FOLEY CATHETER | TELEFLEX MEDICAL | KOB | 570622 | 11JG20 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-10-30 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.