MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for URINE METER manufactured by .
[89530861]
(b)(6). (b)(4). Based on the available information, this event is deemed a product malfunction. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. 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
[89530862]
It was reported by the distributor that the customer experienced an issue with seeing black spots in a used measuring chamber of the device at the beginning of 2017. It is unknown what lot or model number of the product was used, but it was noted as a unometer convatec product. " no further details have been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00060 |
| MDR Report Key | 6900999 |
| Date Received | 2017-09-28 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-09-28 |
| 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 | 2017-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-28 |