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 2018-01-29 for URINE METER 25001183 manufactured by .
[98738760]
(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
[98738761]
The hospital's material resource department reported that "urine could not flow from tube to chamber as if the urine do not exert enough pressure to open the non-return valve and flow to the collecting chamber? When using an unometer device in the neonatal intensive care unit. There was no reported patient harm. The unometer device was replaced using the same brand with a different lot number. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2018-00001 |
| MDR Report Key | 7225818 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-01-29 |
| Date Mfgr Received | 2018-03-05 |
| Date Added to Maude | 2018-01-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-01-29 |
| Model Number | 25001183 |
| Lot Number | 311451 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-01-29 |