MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-12 for RESOUND PZ861-DRWC 20928601 manufactured by Gn Hearing A/s.
| Report Number | 3005650109-2020-00006 |
| MDR Report Key | 9699812 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-10-28 |
| Date Added to Maude | 2020-02-12 |
| 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. LARS HAGANDER |
| Manufacturer Street | LAUTRUPBJERG 7 |
| Manufacturer City | BALLERUP, COPENHAGEN 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2750 |
| Manufacturer G1 | GN HEARING A/S |
| Manufacturer Street | LAUTRUPBJERG 7 |
| Manufacturer City | BALLERUP, COPENHAGEN 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOUND |
| Generic Name | PREZA 8 |
| Product Code | OSM |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-02-12 |
| Model Number | PZ861-DRWC |
| Catalog Number | 20928601 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 BALLERUP, COPENHAGEN 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |