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 2019-08-27 for BHT ULTIMA ACTIVATOR II REUSABLE DRIVE MECH UA-5001 manufactured by Maquet Cardiovascular Llc.
| Report Number | 2242352-2019-00978 |
| MDR Report Key | 8935668 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-27 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-08-02 |
| Date Mfgr Received | 2019-08-02 |
| Device Manufacturer Date | 2018-11-30 |
| Date Added to Maude | 2019-08-27 |
| 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 | BHT |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Product Code | DWS |
| Date Received | 2019-08-27 |
| Model Number | ULTIMA ACTIVATOR II REUSABLE DRIVE MECH |
| Catalog Number | UA-5001 |
| Lot Number | 25143118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-08-27 |