MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-03-23 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[103299408]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103299409]
The patient reported that they had a uti and was sick for a week. It was indicated that this was painful for the patient, but they took medication and now felt better. The issue was resolved at the time of the report. There were no further complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[107570838]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107570839]
Additional information was received from a healthcare professional (hcp). It was reported that the patient started getting utis on (b)(6) 2018, but they did have a history of them, dating back to (b)(6) 2016. The cause was escherichia coli (e. Coli) and the utis were related to the patient's underlying urinary dysfunction, but the hcp stated they were not related to the device/therapy.
Patient Sequence No: 1, Text Type: D, B5
[108229966]
Review of this mdr and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2018-00871 |
| MDR Report Key | 7365449 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-03-23 |
| Date of Report | 2018-05-14 |
| Date Mfgr Received | 2018-05-10 |
| Device Manufacturer Date | 2016-03-14 |
| Date Added to Maude | 2018-03-23 |
| 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 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | ADVANCED URO-SOLUTIONS, L.L.C. |
| Manufacturer Street | 7842 HICKORY FLAT HIGHWAY SUITE D |
| Manufacturer City | WOODSTOCK,GA MN 301881200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 301881200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NURO |
| Generic Name | STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION |
| Product Code | NAM |
| Date Received | 2018-03-23 |
| Model Number | 3533 |
| Catalog Number | 3533 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED URO-SOLUTIONS, L.L.C. |
| Manufacturer Address | 7842 HICKORY FLAT HIGHWAY SUITE D WOODSTOCK,GA MN 301881200 US 301881200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-23 |