MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-20 for URINE METER 158101310190 manufactured by .
[87868480]
This following complaint originated from (b)(6) hospital, but was reported via the distributor: (b)(6). (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[87868481]
The distributor received a report from the nurse that? It is difficult to drain the urine from the tubing to the chamber.? The reporter indicated that the staff nurse had to shake the tubing in order to force the urine to flow. It was further reported that the patient required a urine test. The unometer safeti plus was used for one (1) day, and then replaced with another unometer safeti plus device. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00050 |
| MDR Report Key | 6879869 |
| Date Received | 2017-09-20 |
| Date of Event | 2017-08-27 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2017-09-20 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2017-09-20 |
| Model Number | 158101310190 |
| Lot Number | 303363 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-20 |