MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-12-26 for UROPASS AS 13/15FR X 46 CM 5/BX 61346BX manufactured by Teleflex Medical Oem.
Report Number | 2951238-2019-01233 |
MDR Report Key | 9521425 |
Report Source | USER FACILITY |
Date Received | 2019-12-26 |
Date of Report | 2020-02-21 |
Date of Event | 2019-09-10 |
Date Mfgr Received | 2020-02-03 |
Date Added to Maude | 2019-12-26 |
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. CONNIE TUBERA |
Manufacturer Street | 2400 RINGWOOD AVENUE |
Manufacturer City | SAN JOSE CA 95131 |
Manufacturer Country | US |
Manufacturer Postal | 95131 |
Manufacturer Phone | 4089355124 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | UROPASS AS 13/15FR X 46 CM 5/BX |
Generic Name | UROPASS |
Product Code | KNY |
Date Received | 2019-12-26 |
Returned To Mfg | 2019-10-22 |
Model Number | 61346BX |
Lot Number | 09J1500011 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX MEDICAL OEM |
Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-12-26 |