MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-11-05 for URINE METER 158101310190 manufactured by Unomedical Zavodskaya Street 50.
[126160572]
(b)(4). Based on the available information, this event is deemed to be a reportable malfunction. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. 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
[126160573]
It was reported that the unometer safeti plus system created an air-lock during use and the tubing was not kinked. The nurse indicated that the patient was uncomfortable and had a restless feeling because, the patient's bladder was filling, but urine was not flowing into the system. The nurse reported that when the tubing was lifted/shaken, the urine started to flow into the diuresis chamber. The device was kept in use. The product lot number was requested but, could not obtain. No further information or photograph was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2018-00019 |
| MDR Report Key | 8038207 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-11-05 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-11-05 |
| 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 | 3 |
| Brand Name | URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2018-11-05 |
| Model Number | 158101310190 |
| 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 | 2018-11-05 |