MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-17 for CUSTODIOL SOLUTION manufactured by .
[5657072]
Over the last month multiple bags of custodial solution have been leaking. Diagnosis or reason for use: heart preservation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041573 |
| MDR Report Key | 4627467 |
| Date Received | 2015-03-17 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-03-17 |
| Date Added to Maude | 2015-03-25 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTODIOL SOLUTION |
| Generic Name | CUSTODIAL SOLUTION |
| Product Code | MSB |
| Date Received | 2015-03-17 |
| Lot Number | 1433521 |
| ID Number | 25767-735-45 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-03-17 |