MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-15 for TBD 509047 manufactured by .
[67876381]
Brand name: unometer safeti. Common device name: device urine flow rate measuring, non-electrical. Procode: ffg. (b)(6). Based on the available information, this event is deemed a product malfunction. No patient harm was reported. 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
[67876382]
Complaint reported by a doctor that "the urine did not flow into the collection room" of the device. The device was removed. No further information was available.
Patient Sequence No: 1, Text Type: D, B5
[75535675]
A batch record review was performed; and a non-conformance (nc) from a previous complaint was opened which is associated with this reported issue. The nc has been closed and no further investigation is required. The investigation concluded that the likely root cause for the issue, "stop flow between patient and chamber of the unometer product" cannot be identified based on the information received. This issue will be monitored through the post market product monitoring review process. No additional patient/details has been provided regarding the reported event. Should additional information become available at a later date, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2017-00008 |
| MDR Report Key | 6332648 |
| Date Received | 2017-02-15 |
| Date Mfgr Received | 2017-04-17 |
| Date Added to Maude | 2017-02-15 |
| 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 | TBD |
| Product Code | FFG |
| Date Received | 2017-02-15 |
| Model Number | 509047 |
| Lot Number | 227856 |
| Device Expiration Date | 2020-01-01 |
| 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 | 2017-02-15 |