MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-02 for URINE METER 158100140190 manufactured by Unomedical Zavodskaya Street 50.
[116070297]
Common device name: device, urine flow rate measuring, non-electrical, disposable. Product code: ffg. (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. Additional patient/event details have been requested but none have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[116070298]
It was reported that a? Urinary stasis in the double lumen tube? Issue occurred in a total of three (3) unometer safeti-plus device (s). There was no reported patient harm. A photograph depicting the reported issue was provided. Although requested, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2018-00012 |
| MDR Report Key | 7742643 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-02 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-08-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer G1 | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Street | FE UNOMEDICAL LTD MINSK REGION |
| Manufacturer City | MINSKAYA VOBLASTS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | URINE METER |
| Product Code | FFG |
| Date Received | 2018-08-02 |
| Model Number | 158100140190 |
| Lot Number | 307880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Address | FE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-02 |