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 2017-07-27 for URINE METER 25001183 manufactured by .
[81438991]
(b)(6). Based on the available information, this event is deemed a product malfunction. This is the second report about a second defective device used for the same patient. 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
[81438992]
This is the second report about a second defective device used for the same patient: 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. " clarification was obtained: reporter stated that the patient experienced urinary retention and "the nurses realized that the correct urine descent was not being produced since they started using the device. When they observed this incidence, they made disconnections of it from the bladder catheter or they pricked it to favor the air entrance in the system and favor the urine descent. " 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. " the reporter verified that the indwelling catheter was flushed, was patent and returned no clots or sediment, but urine did not flow.?? Staff replaced unit in accordance with hospital protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00040 |
| MDR Report Key | 6747633 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-07-27 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-07-27 |
| 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 | 2017-07-27 |
| Model Number | 25001183 |
| Lot Number | 307324 |
| 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 | 2017-07-27 |