MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2015-06-03 for UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER 158100510190 manufactured by Unomedical Ltd..
[5894431]
The nurse reports the unometer safeti open/close lever is in the closed position (in order to measure urine output) however, after one hour it is observed the measurement chamber is empty; urine flows into the collection bag making it impossible to obtain the urine measurement.
Patient Sequence No: 1, Text Type: D, B5
[13346683]
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 the malfunction. Should additional information become available, a follow-up report will be submitted. This complaint involves two devices, therefore a separate fda form 3500a will be drafted for each device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00052 |
| MDR Report Key | 4817917 |
| Report Source | 01,06,08 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-20 |
| Date of Event | 2015-05-05 |
| Date Mfgr Received | 2015-05-20 |
| Date Added to Maude | 2015-07-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, DIRECTOR |
| Manufacturer Street | 211 AMERICAN AVENUE |
| 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 SAFETI PLUS WITH LUER-LOCK & LUER |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-06-03 |
| Model Number | 158100510190 |
| 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 DIST MINSK REG MINSKAYA 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-03 |