MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for BALLOON WEDGE PRESSURE CATHETER SWAN GANZ CATHETER A1-07124 manufactured by Arrow Teleflex.
| Report Number | MW5090207 |
| MDR Report Key | 9156281 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-10-02 |
| Date of Event | 2019-09-30 |
| Date Added to Maude | 2019-10-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BALLOON WEDGE PRESSURE CATHETER SWAN GANZ CATHETER |
| Generic Name | CATHETER FLOWDIRECTED |
| Product Code | DYG |
| Date Received | 2019-10-03 |
| Returned To Mfg | 2019-10-02 |
| Catalog Number | A1-07124 |
| Lot Number | 16F1960032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW TELEFLEX |
| Manufacturer Address | MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-03 |