MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-14 for ESOPHYX Z manufactured by .
| Report Number | 3005473391-2019-00125 |
| MDR Report Key | 9188920 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-14 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-16 |
| Date Added to Maude | 2019-10-14 |
| 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. VISHNU VENKATESAN |
| Manufacturer Street | 18109 NE 76TH ST SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4253079248 |
| Manufacturer G1 | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Street | 18109 NE 76TH ST SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHYX Z |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2019-10-14 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-14 |