MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-06 for HSK III SEAL (4.5MM) AORTIC CUTTERS, 5 PACK (4.3MM), AC-3043 AC-3043 manufactured by Maquet Cardiovascular Llc.
| Report Number | 2242352-2019-01342 |
| MDR Report Key | 9423893 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-06 |
| Date of Report | 2019-12-04 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-07-11 |
| Date Added to Maude | 2019-12-06 |
| 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 SEAL (4.5MM) |
| Generic Name | CUTTER, SURGICAL |
| Product Code | FZT |
| Date Received | 2019-12-06 |
| Model Number | AORTIC CUTTERS, 5 PACK (4.3MM), AC-3043 |
| Catalog Number | AC-3043 |
| Lot Number | 25147248 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-12-06 |