MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a f,f,f report with the FDA on 2019-08-06 for AURICAL VSM, 1053 FREEFIT 8-62-49100 manufactured by Natus Medical Denmark (gn Otometrics).
| Report Number | 9612197-2019-00002 |
| MDR Report Key | 8864247 |
| Report Source | F,F,F |
| Date Received | 2019-08-06 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-05-14 |
| Device Manufacturer Date | 2019-07-07 |
| 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 | MISS LOUISE CALLANAN |
| Manufacturer Street | HOERSKAETTEN 9, |
| Manufacturer City | TAASTRUP, 2630 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2630 |
| Manufacturer G1 | NATUS MEDICAL DENMARK (GN OTOMETRICS |
| Manufacturer Street | ) IDA BUSINESS PARK |
| Manufacturer City | GORT GALWAY, CO H91PD |
| Manufacturer Country | 92 |
| Manufacturer Postal Code | EI |
| Single Use | 3 |
| Remedial Action | N |
| Previous Use Code | 0 |
| Removal Correction Number | R |
| Event Type | 0 |
| Distributor Name | M |
| Type of Report | 0 |
| Brand Name | AURICAL VSM, 1053 FREEFIT |
| Generic Name | AURICAL VSM, 1053 FREEFIT |
| Product Code | ETW |
| Date Received | 2019-08-06 |
| Returned To Mfg | 2019-07-08 |
| Model Number | 8-62-49100 |
| Catalog Number | 8-62-49100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL DENMARK (GN OTOMETRICS) |
| Manufacturer Address | HOERSKAETTEN 9, TAASTRUP, 2630 DA 2630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-06 |