MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-05 for NEOTRACT UROLIFT SYSTEM UL400 AN00090 manufactured by Neotract Inc..
Report Number | 3005791775-2019-00029 |
MDR Report Key | 8963406 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-09-05 |
Date of Report | 2019-09-04 |
Date of Event | 2019-08-06 |
Date Mfgr Received | 2019-08-06 |
Date Added to Maude | 2019-09-05 |
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 | 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 | 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 | 2019-09-05 |
Model Number | UROLIFT SYSTEM |
Catalog Number | AN00090 |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
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. Other | 2019-09-05 |