MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-13 for T-DOC AIR-CHARGED SINGLE SENSOR COUDE CATHETER CAT878 TDOC-7FSC manufactured by Laborie Medical Technologies Canada Ulc.
| Report Number | 9681424-2019-00002 |
| MDR Report Key | 8695411 |
| Date Received | 2019-06-13 |
| Date of Report | 2019-06-13 |
| Date of Event | 2019-05-15 |
| Device Manufacturer Date | 2018-11-16 |
| Date Added to Maude | 2019-06-13 |
| 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. NICOLE BOSER |
| Manufacturer Street | 6415 NORTHWEST DRIVE UNIT 10 |
| Manufacturer City | MISSISSAUGA, ONTARIO L4V1X1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4V1X1 |
| Manufacturer G1 | CLINICAL INNOVATIONS LLC |
| Manufacturer Street | 747 W 4170 ST |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T-DOC AIR-CHARGED SINGLE SENSOR COUDE CATHETER |
| Generic Name | CATHETER FOR USE WITH URODYNAMIC SYSTEMS |
| Product Code | FEN |
| Date Received | 2019-06-13 |
| Model Number | CAT878 |
| Catalog Number | TDOC-7FSC |
| Lot Number | 181576 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABORIE MEDICAL TECHNOLOGIES CANADA ULC |
| Manufacturer Address | 6415 NORTHWEST DR UNIT 10 MISSISSAUGA, L4V1X1 CA L4V1X1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-13 |