MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-12-01 for URINE METER 158101310190 manufactured by .
[93665526]
(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
[93665527]
A nurse reported that? The tubes of the unometer is not allowing small amount of urine to go with gravity.? It was reported that approximately 1 hour after connecting the unometer to the catheter, the care provider noted urine was backing up in the inlet tubing. It was further reported that the tube of the unometer had to be lifted every hour in order for the urine to flow. There was no flow of urine into the measuring chamber without manipulation of the tube. After manipulation of the tube, approximately 20-30ml of urine entered the measuring chamber. The unometer was replaced another unometer with the same lot number. There was no harm to the patient. Although requested, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00072 |
| MDR Report Key | 7075669 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-12-01 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2018-02-12 |
| Date Added to Maude | 2017-12-01 |
| 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 | 3 |
| Brand Name | URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2017-12-01 |
| Model Number | 158101310190 |
| Lot Number | 307503 |
| 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 | 2017-12-01 |