MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-07-26 for UROPASS AS 13/15FR X 38 CM 5/BX 61338BX manufactured by Teleflex Medical Oem.
| Report Number | 2951238-2019-01025 |
| MDR Report Key | 8833311 |
| Report Source | FOREIGN |
| Date Received | 2019-07-26 |
| Date of Report | 2019-08-06 |
| Date of Event | 2019-07-02 |
| Date Mfgr Received | 2019-07-30 |
| Date Added to Maude | 2019-07-26 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 38 CM 5/BX |
| Generic Name | UTERAL ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2019-07-26 |
| Returned To Mfg | 2019-07-08 |
| Model Number | 61338BX |
| Lot Number | 92H |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-07-26 |