MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-06-10 for UNOMETER 500, URINE METER (WITH FIXED BAG AND 25039742 manufactured by Unomedical Ltd..
[22034956]
It was reported the urinometer disconnected from the patient's catheter while in use. This issue occurred an unknown number of times with an unknown number of devices. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[22348867]
Based on the available information, this event is deemed a reportable malfunction. No further information was available at the time of the report. There were no reports of the patient being harmed as a result of this malfunction. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[39244277]
Additional informational was received june 09, 2015. The lot number or product evaluation sample is available. A detailed investigation or batch review cannot be conducted. Therefore this evaluation will be closed and will be monitored through our post market monitoring review process. No additional patient/event details have been provided to date. Should additional information become available a follow up report will be submitted. Reported to the fda on june 30, 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00055 |
| MDR Report Key | 4837971 |
| Report Source | 01,06 |
| Date Received | 2015-06-10 |
| Date of Report | 2015-05-28 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2015-06-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW WALENCIAK |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNOMETER 500, URINE METER (WITH FIXED BAG AND |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-06-10 |
| Model Number | 25039742 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION, MINSKAYA VOBLASTS 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-10 |