MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-24 for URINE METER 25104742 manufactured by Unomedical Zavodskaya Street 50.
[186322260]
Mdr 3007966929-2020-00012 / device 1 of 1. (b)(6) hospital. Report source: (b)(6). Device manufacture date: 06/2019. Based on the available information, this event is deemed to be a reportable malfunction. Additional patient/event has been requested but, no additional information has been received to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186322261]
It was reported by user facility that the device allowed "very little output". It is reported that the patient had a 10 french foley catheter (brand unknown) placed prior to commencement of surgery. When the patient was transported to pediatric intensive care unit (picu) post-surgery it was noted that there was "very little output noted in the unometer". The staff "flushed the catheter, but report despite flushing easily, the catheter did not drain anything". The patient was then re-catheterized and the unometer device was changed with an "immediate" outflow of 200ml into the unometer. Upon inspection by the user facility the note "white flap below tubing connection in unometer, not present in other same devices". It was further reported that it is? Unclear if injury occurred,? But no harm was reported. No photograph depiction the reported complaint issue submitted by the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2020-00012 |
| MDR Report Key | 9873372 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-24 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-24 |
| 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 Phone | 3365424681 |
| 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 | 3 |
| Brand Name | URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2020-03-24 |
| Model Number | 25104742 |
| Lot Number | 327051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-24 |