MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-04 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[74418710]
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
[74418711]
A patient reported that the last ptnm therapy session they had on (b)(6) 2017 really affected them. The patient stated that they did not realize that they had a bladder infection. After they had their last session "down really low" started hurting and it hurt through the weekend. They went to the healthcare provider (hcp) and they had a urinary tract infection (uti). They were unsure if the treatment had anything to do with it. The patient said it still kind of hurts when they bend over and they were "pouring a lot", and "having to change pads really often. " they stated they had "been really kind of sick this week. " the patient stated they were happy thinking that it would help, but the last week made them unsure. They were so worried about their bladder because their grandmother had bladder cancer, so they may have to do more testing if it continues. The patient further reported that the hcp gave them a prescription and when they finish it they will be taking something every day. They thought that they would continue on once a month, but they did not know. They were still taking meds and their symptoms were not better by the time they finished the meds, they would go back to see the hcp. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[107237224]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012165443-2017-00018 |
| MDR Report Key | 6544349 |
| Report Source | CONSUMER |
| Date Received | 2017-05-04 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-05-04 |
| 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 | 2017-05-04 |
| 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. Required No Informationntervention | 2017-05-04 |