MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-17 for HSK III SYSTEM (4.3MM) HST III SYSTEM (4.3MM) HSK-3043 manufactured by Maquet Cardiovascular Llc.
| Report Number | 2242352-2020-00151 |
| MDR Report Key | 9717946 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2020-02-17 |
| 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 Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HSK III SYSTEM (4.3MM) |
| Generic Name | CLAMP, VASCULAR |
| Product Code | DXC |
| Date Received | 2020-02-17 |
| Returned To Mfg | 2020-02-11 |
| Model Number | HST III SYSTEM (4.3MM) |
| Catalog Number | HSK-3043 |
| Lot Number | 25146972 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR LLC |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |