MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for NEOTRACT UROLIFT SYSTEM UL400 AN00155 manufactured by Neotract, Inc..
[175172439]
On (b)(6) 2019, neotract became aware of a (b)(6) year-old patient, with a past medical history of cardiac artery disease (cad) and other cardiac events, who underwent a successfully completed prostatic urethral lift (pul) procedure on (b)(6) 2019. Post procedure, the physician reported that the patient experienced somnolence and confusion, and he became unconscious. The patient underwent cpr and received defibrillation with no response. The physician reported that he was then transferred to a hospital where he expired later that day. The physician stated he does not believe the pul procedure caused the patient? S death. There is a lack of medical information to conclusively link the patient? S death with either the device or the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005791775-2020-00006 |
| MDR Report Key | 9594067 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| 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 | 0 |
| 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. Death | 2020-01-15 |