MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for UNKNOWN_ARRINEX_PRODUCT UNK_INS manufactured by Arrinex, Inc..
| Report Number | 3015132143-2020-00003 |
| MDR Report Key | 9869536 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-23 |
| 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. TRACEY HENRY |
| Manufacturer Street | 127 INDEPENDENCE DR. |
| Manufacturer City | MENLO PARK CA |
| Manufacturer Country | US |
| Manufacturer Phone | 8883086018 |
| Manufacturer G1 | ARRINEX, INC. |
| Manufacturer Street | 127 INDEPENDENCE DR. |
| Manufacturer City | MENLO PARK CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_ARRINEX_PRODUCT |
| Generic Name | CRYOABLATION DEVICE |
| Product Code | GEH |
| Date Received | 2020-03-23 |
| Model Number | UNKNOWN |
| Catalog Number | UNK_INS |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARRINEX, INC. |
| Manufacturer Address | 127 INDEPENDENCE DR. MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |