MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-22 for UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER 158101310190 manufactured by Unomedical Ltd..
[5580965]
It was reported the urine did not flow from the urinary catheter into the urinometer. The device was disconnected and replaced. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[13230369]
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. Additional patient/event details have been requested. Should additional information become available, a follow-up report will be submitted. This complaint involves five devices, therefore a separate fda form 3500a will be drafted for each device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2015-00039 |
| MDR Report Key | 4723521 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-10 |
| Date Added to Maude | 2015-06-04 |
| 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, INTERIM. ASSOC |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 274090000 |
| Manufacturer Country | US |
| Manufacturer Postal | 274090000 |
| 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 |
| Product Code | EXR |
| Date Received | 2015-04-22 |
| Model Number | 158101310190 |
| Lot Number | 181888 |
| 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 00002227 BO 000022275 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-22 |