MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-02-12 for UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER 158101310190 manufactured by Unomedical Ltd.
[5407312]
It was reported the pt's urine flowed directly into the main collection chamber of the urinometer, bypassing the initial five hundred milliliter chamber. Upon discovery, the device was discontinued. No pt consequences were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12891495]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the pt 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
| Report Number | 3007966929-2015-00028 |
| MDR Report Key | 4528097 |
| Report Source | 01,08 |
| Date Received | 2015-02-12 |
| Date of Report | 2015-02-02 |
| Date Mfgr Received | 2015-02-02 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-03-16 |
| 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, INT ASSC DIR |
| 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 SAFETI PLUS - WITH LUER-LOCK AND LUER |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2015-02-12 |
| Model Number | 158101310190 |
| Lot Number | 166482 |
| Device Expiration Date | 2019-07-01 |
| 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 | 2015-02-12 |