MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-13 for ESOPHYX Z R2007 manufactured by Endogastric Solutions, Inc..
| Report Number | 3005473391-2020-00130 |
| MDR Report Key | 9831945 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-05-10 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3079248 |
| Manufacturer G1 | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Street | 18109 NE 76TH ST SUITE 100 |
| Manufacturer City | REDMOND, WA |
| Manufacturer Country | US |
| 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 | 2020-03-13 |
| Model Number | R2007 |
| Catalog Number | R2007 |
| Lot Number | 402767 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Address | 18109 NE 76TH ST SUITE 100 REDMOND, WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-13 |