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 2017-04-03 for NURO 3533 manufactured by Advanced Uro-solutions, L.l.c..
[71529234]
Patient Sequence No: 1, Text Type: N, H10
[71529235]
A patient reported that their urinary incontinence was worse than before. They also stated that they fell on (b)(6) 2017 and had been having knee swelling since. The patient mentioned they saw their healthcare provider on (b)(6) 2017 and they advised the patient to use ice to reduce the swelling. The ptnm therapy sessions began on (b)(6) 2017. It was noted that the patient has a past medical history of rheumatoid arthritis. Follow up from the healthcare provider, on (b)(6) 2017, noted that the patient had a urinary tract infection at the start of treatment and they were treated for the uti on (b)(6) 2017. The hcp noted that per the staff at the patient's home, they patient has a history of knee/joint pain. They were unaware of the symptoms worsening and the patient falling. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[73155400]
Patient Sequence No: 1, Text Type: N, H10
[73155401]
Additional information from the healthcare provider reported that the cause of the urinary tract infection was unknown. They stated that they could not say that the ptnm device or therapy caused the uti, worsened symptoms or fall. The staff at the patient's home facility stated that the patient had multiple falls and leg pain prior to the ptnm therapy. The patient does have assistance from home care staff with transfers when they come to their visits. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[101041438]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[119811712]
Analysis of the nuro device (b)(4) found no anomalies. The device passed all functional testing. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123842490]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-01242 |
| MDR Report Key | 6453611 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-04-03 |
| Date of Report | 2018-10-05 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2016-02-29 |
| Date Added to Maude | 2017-04-03 |
| 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 | 2017-04-03 |
| Model Number | 3533 |
| Catalog Number | 3533 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-04-03 |