MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-06 for 158101210190 manufactured by .
[72252409]
Brand name - unometer safeti+ 150cm 2l (1
Patient Sequence No: 1, Text Type: N, H10
[72252410]
Complaint received from hospital nurse reporting that "the urine stay stopped in the kombikon valve and doesn't flow. " no further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00016 |
| MDR Report Key | 6463330 |
| Date Received | 2017-04-06 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-06-20 |
| Date Added to Maude | 2017-04-06 |
| 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 |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2017-04-06 |
| Model Number | 158101210190 |
| Lot Number | 195037 |
| 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 | 2017-04-06 |