MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-02-26 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100140190 manufactured by Unomedical Ltd..
[39208093]
Height: 160 feet. Based on the available information, this event is deemed a reportable malfunction. No 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 product monitoring review process. Additional information has been requested however, 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 february 26, 2016 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39208094]
It was reported that the space of the sampling port is blocked with urine sediment and it is difficult to take the sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2016-00007 |
| MDR Report Key | 5463536 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-02 |
| Date of Event | 2016-02-02 |
| Date Mfgr Received | 2016-02-02 |
| Date Added to Maude | 2016-02-26 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| 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 | DEVICE, URINE FLOW RATE MEASURING |
| Product Code | FFD |
| Date Received | 2016-02-26 |
| Model Number | 158100140190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 VOBLAST 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-26 |