D
Patient 1
IT WAS REPORTED 'THE CATHETER THAT CONNECTED THE FOLEY CATHETER TO THE URINOMETER MEASURING CHAMBER HAD TO BE MANIPULATED TO ALLOW THE URINE FLOW'. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.
MAUDE MDR 4810769
- MDR report key
- 4810769
- Report number
- 3007966929-2015-00050
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-01-26
- Date received
- 2015-06-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MATTHEW WALENCIAK, INTERIM ASSOC.
- Address
- 211 AMERICAN AVE. GREENSBORO NC 27409 US
- Phone
- 908-908-9083
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER | UNOMEDICAL LTD. | EXR | 158100410190 | 655189 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-01 | 0 |
Event Narratives#
N
Patient 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.