MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for UROLIFT UL400-4 manufactured by Neotract, Inc..
[185017961]
Urolift devices misfired inside the patient with two different urolift kits. Product misfire x 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882654 |
| MDR Report Key | 9882654 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-03 |
| Report Date | 2020-02-07 |
| Date Reported to FDA | 2020-02-07 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROLIFT |
| Generic Name | IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM |
| Product Code | PEW |
| Date Received | 2020-03-26 |
| Catalog Number | UL400-4 |
| Lot Number | 73K1900163 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-26 |