MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-19 for NEOTRACT UROLIFT SYSTEM UL400 AN00155 manufactured by Neotract, Inc..
[180040964]
On 21 jan 2020, neotract was notified of a patient who underwent a successful prostatic urethral lift (pul) procedure on (b)(6) 2020. The procedure was described to be uneventful and no complications were reported. On the morning of (b)(6) 2020, the home healthcare nurse found the patient lying on the bathroom floor. Later that day, the physician reported that he was notified the patient coded at home and expired. The physician stated that he does not believe the patient death was related to the pul procedure, and declined to provide any additional information. On 30 jan 2020, during follow up call, the physician declined to provide any further details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005791775-2020-00009 |
| MDR Report Key | 9729662 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-18 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-02-19 |
| Model Number | UL400 |
| Catalog Number | AN00155 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 1. Death | 2020-02-19 |