MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-29 for ESTEEM 2001 902001-003 manufactured by Envoy Medical Corporation.
| Report Number | 3004007782-2019-00005 |
| MDR Report Key | 8944734 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-08-29 |
| Date of Report | 2019-08-29 |
| Date of Event | 2019-08-22 |
| Device Manufacturer Date | 2018-09-24 |
| Date Added to Maude | 2019-08-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MAKSIM TROFIMOVICH |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 551108057 |
| Manufacturer Country | US |
| Manufacturer Postal | 551108057 |
| Manufacturer Phone | 6513618029 |
| Manufacturer G1 | ENVOY MEDICAL CORPORATION |
| Manufacturer Street | 4875 WHITE BEAR PARKWAY |
| Manufacturer City | WHITE BEAR LAKE MN 551108057 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551108057 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESTEEM |
| Generic Name | ESTEEM II, PRODUCT CODE: OAF |
| Product Code | OAF |
| Date Received | 2019-08-29 |
| Model Number | 2001 |
| Catalog Number | 902001-003 |
| Lot Number | EMC0006353 |
| Device Expiration Date | 2019-09-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENVOY MEDICAL CORPORATION |
| Manufacturer Address | 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-29 |