MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for NEOTRACT UROLIFT SYSTEM UL400 AN00136 manufactured by Neotract, Inc..
Report Number | 3005791775-2020-00002 |
MDR Report Key | 9569102 |
Date Received | 2020-01-09 |
Date of Report | 2020-01-09 |
Date of Event | 2019-11-06 |
Date Mfgr Received | 2019-11-12 |
Date Added to Maude | 2020-01-09 |
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 | 4155 HOPYARD ROAD |
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 |
Generic Name | UROLIFT SYSTEM |
Product Code | PEW |
Date Received | 2020-01-09 |
Returned To Mfg | 2019-11-12 |
Model Number | UL400 |
Catalog Number | AN00136 |
Lot Number | 73G1900127 / 2695142 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NEOTRACT, INC. |
Manufacturer Address | 1059 SANDHURST VALLEJO CA 94591 US 94591 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-09 |