MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for ASU1201 manufactured by Cardinal Health.
[95469768]
Patient Sequence No: 1, Text Type: N, H10
[95469769]
Prior to utilizing on patient, the trumpet valve device was tested by the attending surgeon. The red button did not properly function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7137504 |
| MDR Report Key | 7137504 |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-12-12 |
| Report Date | 2017-12-12 |
| Date Reported to FDA | 2017-12-12 |
| Date Reported to Mfgr | 2017-12-12 |
| Date Added to Maude | 2017-12-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CATHETER, IRRIGATION |
| Product Code | FEH |
| Date Received | 2017-12-21 |
| Model Number | ASU1201 |
| Catalog Number | ASU1201 |
| Lot Number | 041730 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-21 |