MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-17 for CARDIAC OUTPUT BRIDGE 041400-352 manufactured by Cobe Cardiovascular, Inc..
[13801]
Cracks in "4" different bridges which resulted in fluid leakage from ports and small amount of blood leakage from one port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005634 |
| MDR Report Key | 21208 |
| Date Received | 1995-04-17 |
| Date of Report | 1995-03-17 |
| Date of Event | 1995-03-16 |
| Date Added to Maude | 1995-04-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIAC OUTPUT BRIDGE |
| Generic Name | CARDIAC OUTPUT BRIDGE |
| Product Code | DPW |
| Date Received | 1995-04-17 |
| Model Number | 041400-352 |
| Lot Number | 1224998 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21188 |
| Manufacturer | COBE CARDIOVASCULAR, INC. |
| Manufacturer Address | LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-04-17 |