MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for IS PLEURX DRAINAGE KIT 1000ML 50-7510 manufactured by Carefusion, Inc.
| Report Number | 9680904-2019-00019 |
| MDR Report Key | 9097747 |
| Date Received | 2019-09-20 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2019-08-26 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2019-09-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IS PLEURX DRAINAGE KIT 1000ML |
| Generic Name | APPARATUS, SUCTION, PATIENT CARE |
| Product Code | DWM |
| Date Received | 2019-09-20 |
| Catalog Number | 50-7510 |
| Lot Number | 0001282859 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | ZONA FRANCA LAS AMERICAS SANTO DOMINGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-20 |