MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-21 for EKOSONIC ENDOVASCULAR CATHETER 500-55112 manufactured by Ekos Corporation.
| Report Number | 3001627457-2020-00006 |
| MDR Report Key | 9741591 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-10-24 |
| Date Added to Maude | 2020-02-21 |
| 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. SANDARA BAUSBACK-ABALLO |
| Manufacturer Street | 300 CONSHOHOCKEN STATE RD, 300 FOUR FALLS CORPORATE CTR. |
| Manufacturer City | WEST CONSHOHOCKEN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 3311537 |
| Manufacturer G1 | EKOS CORPORATION |
| Manufacturer Street | 11911 NORTH CREEK PARKWAY |
| Manufacturer City | BOTHELL, WA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EKOSONIC ENDOVASCULAR CATHETER |
| Generic Name | EKOSONIC ENDOVASCULAR CATHETER |
| Product Code | KRA |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 500-55112 |
| Catalog Number | 500-55112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EKOS CORPORATION |
| Manufacturer Address | 11911 NORTH CREEK PARKWAY S BOTHELL, WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |