MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-08-16 for CRYOICE? CRYOFORM CRYO-ABLATION PROBE A000957 manufactured by Atricure, Inc..
| Report Number | 3011706110-2019-00039 |
| MDR Report Key | 8901462 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-08-16 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-06-26 |
| Date Mfgr Received | 2019-07-19 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2019-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. JOHN EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137554563 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOICE? CRYOFORM CRYO-ABLATION PROBE |
| Generic Name | CRYOICE? CRYOFORM CRYO-ABLATION PROBE |
| Product Code | GXH |
| Date Received | 2019-08-16 |
| Returned To Mfg | 2019-08-19 |
| Model Number | CRYOF |
| Catalog Number | A000957 |
| Lot Number | 90278 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-16 |