MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for NEOTRACT UROLIFT SYSTEM UL400 AN00090 manufactured by Neotract, Inc..
| Report Number | 3005791775-2020-00016 |
| MDR Report Key | 9859745 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-20 |
| 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 | MS KATHYRENE LOGRONO |
| Manufacturer Street | 4155 HOPYARD ROAD |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9253296521 |
| Manufacturer G1 | NEOTRACT, INC. |
| Manufacturer Street | 4155 HOPYARD ROAD |
| 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 |
| Generic Name | UROLIFT SYSTEM |
| Product Code | PEW |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-01-24 |
| Model Number | UL400 |
| Catalog Number | AN00090 |
| Lot Number | P40914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOTRACT, INC. |
| Manufacturer Address | 4155 HOPYARD ROAD PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |