FDA Adverse Event
Malfunction
Summary report: N
UM500 1100/2L/BO
MDR report key: 5153589
·
Received October 15, 2015
Report
- Report Number
- 3007966929-2015-30325
- Event Type
- Malfunction
- Date Received
- October 15, 2015
- Date of Event
- March 1, 2012
- Report Date
- February 27, 2014
- Manufacturer
- UNOMEDICAL LTD
- Product Code
- FFG
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LEAKAGE BETWEEN THE CHAMBER AND THE BAG IN MANY OF THE UNOMETERS. CONSEQUENTLY, THE URINE MEASURING WAS INCORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 684993 | UM500 1100/2L/BO | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE | FFG | UNOMEDICAL LTD | 25004182 | 640647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |