MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for URINE METER 158101310190 manufactured by .
[83749362]
(b)(6). (b)(4). Inserted the following statement for clarification- the following complaint originated from (b)(6) hospital but was reported via the distributor: (b)(4). 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
[83749363]
The distributor received reports from two hospitals stating? It is difficult to drain the urine from the tubing to the chamber.? It was reported that the urine did not flow freely in the tubing when the unometer safety was connected to the catheter; however, when the unometer was not connected to the catheter, urine flowed freely. The reporter(s) were unable to provide any additional patient(s) or event(s) details as they stated this information is confidential. Therefore, it is unknown how many patient(s) were involved per the quantity of device(s) reported by each hospital. It was further reported that a patient required a urine test (results were not provided) and the unometer safeti plus was replaced with another unometer. The reporter was unable to provide specifics as to which hospital the following information pertains to. There was no patient(s) harms reported. No further information was able to be obtained or provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00043 |
| MDR Report Key | 6817003 |
| Date Received | 2017-08-24 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-08-24 |
| 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 | 2017-08-24 |
| Model Number | 158101310190 |
| Lot Number | 302598 |
| 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 | 2017-08-24 |