MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-31 for 1081 AURICAL (PMM, C&S, AUD) WITH HI-PRO 8-04-14500 manufactured by Natus Medical Denmark.
| Report Number | 9612197-2020-00001 |
| MDR Report Key | 9655827 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-31 |
| Date of Report | 2020-02-28 |
| Date Facility Aware | 2020-01-17 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-01-31 |
| 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 | NATUS MANUFACTURING LTD IDA BUSINESS PARK |
| Manufacturer City | GORT, CONNACHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MEDICAL DENMARK APS |
| Manufacturer Street | HOERSKAETTEN 9, TAASTRUP 2630, DA |
| Manufacturer Country | DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1081 AURICAL (PMM, C&S, AUD) WITH HI-PRO |
| Generic Name | AURICAL AUD/PMM, 1081 |
| Product Code | EWO |
| Date Received | 2020-01-31 |
| Model Number | 8-04-14500 |
| Catalog Number | 8-04-14500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL DENMARK |
| Manufacturer Address | HOERSKAETTEN 9 TAASTRUP 2630 TAASTRUP, 2630 DA 2630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-31 |