MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2015-03-02 for UNOMETER SAFETI PLUS WITH LUER-LOCK $ LUER 158101310190 manufactured by Unomedical Ltd..
[20979336]
Complainant reported the device was in the patient for three weeks and on (b)(6) 2015 it was noted the open/close lever 'was stiff and difficult to turn and when it was turned open, urine did not flow down' to the collection bag. The complainant further reported the nurse had to replace the device because, the chamber was 'getting full'.
Patient Sequence No: 1, Text Type: D, B5
[21506683]
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. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00031 |
| MDR Report Key | 4563168 |
| Report Source | 01,05,06,08 |
| Date Received | 2015-03-02 |
| Date of Report | 2015-02-17 |
| Date of Event | 2015-02-17 |
| Date Mfgr Received | 2015-02-17 |
| Date Added to Maude | 2015-04-02 |
| 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 | 2015-03-02 |
| Model Number | 158101310190 |
| 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, MINSKA 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-02 |