MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-30 for AMC SILICONE CATHETER A0001 manufactured by Alcyone Lifesciences.
| Report Number | 9255510 |
| MDR Report Key | 9255510 |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-08 |
| Date of Event | 2017-12-08 |
| Report Date | 2019-10-09 |
| Date Reported to FDA | 2019-10-09 |
| Date Reported to Mfgr | 2019-10-30 |
| Date Added to Maude | 2019-10-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Brand Name | AMC SILICONE CATHETER |
| Generic Name | CANNULA, VENTRICULAR |
| Product Code | HCD |
| Date Received | 2019-10-30 |
| Model Number | A0001 |
| Catalog Number | A0001 |
| Lot Number | 14309294 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCYONE LIFESCIENCES |
| Manufacturer Address | 116 JOHN STREET SUITE 300 LOWELL MA 01852 US 01852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-30 |