MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for CARDIOSAVE HYBRID TYPE B PLUG N/A 0998-00-0800-53 manufactured by Datascope Corp. - Mahwah.
| Report Number | 2249723-2020-00531 |
| MDR Report Key | 9906540 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2020-03-31 |
| 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 | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer G1 | DATASCOPE CORP. - MAHWAH |
| Manufacturer Street | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOSAVE HYBRID TYPE B PLUG |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Product Code | DSP |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | 0998-00-0800-53 |
| Lot Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATASCOPE CORP. - MAHWAH |
| Manufacturer Address | 1300 MACARTHUR BLVD MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |