MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-07 for URINE METER 158101310190 manufactured by Unomedical Zavodskaya Street 50.
[175020569]
Mdr 3007966929-2020-00004 / device 1 of 1. (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[175020570]
It was reported by the product distributor that "the urine is not flowing. The bag must be hung very low before the urine runs". According to the complainant the product was initially positioned "per the ifu" when the no flow was noted. The position of the device "was changed together with manipulating the tubing and then the urine flow was reestablished". There was no urine flow "into the tubing/chamber" of the device. Once the device was "placed on the floor the urine started flowing". The product was used on a patient and the patient experienced "some urine retention which was eventually seen on a bladder scan", no amount of retained urine reported. No photographs or videos submitted by the complainant depicting the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2020-00004 |
| MDR Report Key | 9559603 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-01-07 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-07 |
| 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 | 2020-01-07 |
| Model Number | 158101310190 |
| Lot Number | 327320 |
| 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 | 2020-01-07 |