MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-21 for GN RESOUND EY367 19542202 manufactured by Gn Hearing A/s.
| Report Number | 3005650109-2019-00006 |
| MDR Report Key | 8914309 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-21 |
| Date of Report | 2019-08-19 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2019-05-27 |
| Device Manufacturer Date | 2018-05-25 |
| Date Added to Maude | 2019-08-21 |
| 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 LARS HAGANDER |
| Manufacturer Street | LAUTRUPBJERG 7 P.O. BOX 130 |
| Manufacturer City | BALLERUP, COPENHAGEN 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2750 |
| Manufacturer G1 | GN HEARING A/S |
| Manufacturer Street | LAUTRUPBJERG 7 P.O. BOX 130 |
| Manufacturer City | BALLERUP, 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2750 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GN RESOUND |
| Generic Name | ENYA GN RESOUND |
| Product Code | OSM |
| Date Received | 2019-08-21 |
| Returned To Mfg | 2019-06-13 |
| Model Number | EY367 |
| Catalog Number | 19542202 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 BALLERUP, 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-21 |