MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-14 for VITAL-VUE 8886828206 * manufactured by Cardinal Health.
[2074463]
When using this product as it was intended, the irrigation would not pass through with or without pressure. Device was removed from the field and a new one used without any problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2138050 |
| MDR Report Key | 2138050 |
| Date Received | 2011-06-14 |
| Date of Report | 2011-06-14 |
| Date of Event | 2011-06-08 |
| Report Date | 2011-06-14 |
| Date Reported to FDA | 2011-06-14 |
| Date Added to Maude | 2011-06-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL-VUE |
| Generic Name | VITAL VUE IRRIGATION SYSTEM |
| Product Code | HBI |
| Date Received | 2011-06-14 |
| Model Number | 8886828206 |
| Catalog Number | * |
| Lot Number | 9156243 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-14 |