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 2017-05-30 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[76235358]
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
[76235359]
A patient reported that after their second or third session, they didn't have a bit of control. They went to their healthcare provider (hcp) and had a test and they had an infection. They were taking antibiotics for it. The patient also noted they had an ear infection. It was noted that they had completed 3 ptnm therapy sessions. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[86864502]
Patient code (b)(4) is no longer applicable to this event. The event is no longer a reportable event. Evaluation conclusion code is no longer applicable to this event.
Patient Sequence No: 1, Text Type: N, H10
[86864503]
Additional information from the healthcare provider (hcp) reported that the patient has had recurrent uti symptoms since (b)(6) 2015. The urine was sent out to test for the uti and came back negative, no uti. The hcp noted that the patient had an increase in long term urinary symptoms. They also noted that the patient developed symptoms of a uti first, then later developed an ear infection, per patient report. The infection and the lack of control had been resolved. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[98902001]
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
| Report Number | 3007566237-2017-02086 |
| MDR Report Key | 6600120 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-05-30 |
| Date of Report | 2017-06-13 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2016-02-26 |
| Date Added to Maude | 2017-05-30 |
| 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 | 2017-05-30 |
| 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 | 2017-05-30 |