MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-15 for NEOTRACT UROLIFT SYSTEM UL400 AN00155 manufactured by Neotract, Inc..
[176063071]
On 16 december 2019, neotract was notified via us mail regarding a fda medwatch sus voluntary event report, mw5091477, which stated: "my father had a urolift device implanted. Within two weeks he developed a urinary tract infection. After a week of treatment with oral antibiotics, the urine backed into his kidney causing kidney failure and precipitated a stroke. After approx 10 days of hospitalization he had another stroke which ultimately caused his death. " there is a lack of medical information to link the strokes and subsequent death with either the device or the procedure. The amount of time that elapsed between the procedure and the time of patient death is not specified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005791775-2020-00005 |
| MDR Report Key | 9592674 |
| Report Source | OTHER |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-07-05 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-15 |
| 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 | MR. BRIAN GALL |
| Manufacturer Street | 4155 HOPYARD RD |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9253296547 |
| Manufacturer G1 | NEOTRACT, INC. |
| Manufacturer Street | 4155 HOPYARD RD. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOTRACT UROLIFT SYSTEM UL400 |
| Generic Name | UROLIFT SYSTEM |
| Product Code | PEW |
| Date Received | 2020-01-15 |
| Model Number | UROLIFT SYSTEM |
| Catalog Number | AN00155 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOTRACT, INC. |
| Manufacturer Address | 4155 HOPYARD RD. PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2020-01-15 |