MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-20 for NEOTRACT UROLIFT SYSTEM UL400 AN00090 manufactured by Neotract, Inc..
[145612735]
On (b)(4) 2019, neotract was made aware that on (b)(6) 2019, a patient underwent a successful prostatic urethral lift (pul) procedure and was discharged without a catheter with prophylactic antibiotics. On (b)(6) 2019, he reports that he was unable to urinate and experienced pain. He was taken to the emergency room where he was catheterized, given iv antibiotics to treat infection and was admitted to the hospital for eight days. He stated that he was given iv fluids for compromised renal function which normalized after a 24 hour period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005791775-2019-00016 |
| MDR Report Key | 8626127 |
| Report Source | OTHER |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-04-21 |
| Date Added to Maude | 2019-05-20 |
| 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 | MR. BRIAN GALL |
| Manufacturer Street | 4473 WILLOW ROAD, SUITE 100 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9253296547 |
| Manufacturer G1 | NEOTRACT, IN. |
| Manufacturer Street | 4473 WILLOW ROAD, SUITE 100 |
| 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 | 2019-05-20 |
| Model Number | UL400 |
| Catalog Number | AN00090 |
| 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 | 4473 WILLOW ROAD, SUITE 100 PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-20 |