MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-06-29 for URINE METER 25045051 manufactured by .
[78711546]
(b)(6). According to the instructions for use: indications: precautions: [2] during usage the system should be periodically observed to confirm urine flow. In the event of urine blockages:? Ensure that the system is installed correctly. ? Remove any physical obstruction. ? If urine is left in the tube, raise and lower the tube from the midpoint several times. ? If the blockage cannot be removed, replace the system. Instructions for use: installation [6] make sure that the system is installed correctly:? The system hangs near the foot end of the bed, in a vertical position and is located below the level of the patient? S bladder. ? The tube does not kink or has any loops. ? The catheter connector should lay flat. Based on the available information, this event is deemed a product malfunction. 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
[78711547]
Complaint received reporting "urine will not go from the tube into the chamber" of the device and "patient experienced a high level of residual urine in the bladder. " staff reported that the device had been placed horizontally on the bed at the same level as the patient's bladder. However, when the device was placed upright and below the patient's bladder the urine did not flow. No patient harm was reported - device was replaced and urine flow resumed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00032 |
| MDR Report Key | 6677519 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-02 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-06-29 |
| 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 | 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 | URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2017-06-29 |
| Model Number | 25045051 |
| Lot Number | 307907 |
| 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 | 2017-06-29 |