MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-07 for 8-62-41503 manufactured by Natus Medical Denmark.
| Report Number | 9612197-2020-00006 |
| MDR Report Key | 9803591 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-07 |
| Date of Report | 2020-03-07 |
| Date of Event | 2020-02-25 |
| Date Added to Maude | 2020-03-07 |
| 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 | MS MICHELLE GREANEY |
| Manufacturer Street | IDA BUSINESS PARK BUSINESS PK |
| Manufacturer City | GORT, H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MEDICAL DENMARK APS |
| Manufacturer Street | HOERSKAETTEN 9, TAASTRUP 2630 |
| Manufacturer City | 2630 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | AURICAL AUD/PMM, |
| Product Code | EWO |
| Date Received | 2020-03-07 |
| Model Number | 8-62-41503 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL DENMARK |
| Manufacturer Address | HOERSKAETTEN 9 TAASTRUP 2630 2630 DA 2630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-07 |