MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-14 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[67437154]
Patient Sequence No: 1, Text Type: N, H10
[67437155]
A patient reported that since their 12th session on (b)(6) 2017 it seemed as though their symptoms had regressed. The patient had urinary incontinence. The healthcare provider (hcp) did a urine specimen and advised the patient that it did not show an active infection, but it did not come back clear either. So it would be sent to the lab to have a culture done. It was noted that the issue was not resolved at the time of the report.
Patient Sequence No: 1, Text Type: D, B5
[76424288]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[76424289]
Mdr decision corrected to not reportable. No additional supplementals required unless additional information received indicates reportable event.
Patient Sequence No: 1, Text Type: D, B5
[108433344]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012165443-2017-00007 |
| MDR Report Key | 6330708 |
| Report Source | CONSUMER |
| Date Received | 2017-02-14 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-02-14 |
| 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 30188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30188 |
| 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 | 2017-02-14 |
| 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 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-14 |