MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-17 for UROLIFT SYSTEM UL400-4 manufactured by Neotract, Inc..
Report Number | MW5087407 |
MDR Report Key | 8707456 |
Date Received | 2019-06-17 |
Date of Report | 2019-06-13 |
Date of Event | 2019-06-06 |
Date Added to Maude | 2019-06-18 |
Event Key | 0 |
Report Source Code | Voluntary 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 | 0 |
Brand Name | UROLIFT SYSTEM |
Generic Name | IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM |
Product Code | PEW |
Date Received | 2019-06-17 |
Model Number | UL400-4 |
Lot Number | 73C1900665 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NEOTRACT, INC. |
Manufacturer Address | PLEASANTON CA 94588 US 94588 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-06-17 |