MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-02 for URINE METER 25001183 manufactured by .
[81852182]
(b)(4). (b)(6). Based on the available information, this event is deemed a product malfunction. This report is about an unknown number of patients and defective units. Additional details have been requested but not 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
[81852183]
This report is about an unknown number of patients and defective units. Complaint received from a hospital in (b)(6) reporting that "the problem is that when they connected the catheter to the unometer, the urine does not flow. Even in the operating room they had already observed the same problem. " clarification was obtained: reporter stated that before the device was attached to the indwelling catheter, "the urine flowed without any problem. However, at the time of the placement of the device, the professionals observed a significant decrease in the urine descent. " no further information was provided including patient information or outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00039 |
| MDR Report Key | 6761821 |
| Date Received | 2017-08-02 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-08-02 |
| 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 | 2017-08-02 |
| Model Number | 25001183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-02 |