MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-31 for TREX HD HEADBOX 008043 manufactured by Natus Medical Incorporated.
| Report Number | 9612330-2020-00002 |
| MDR Report Key | 9655807 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-11-07 |
| Date Mfgr Received | 2020-01-03 |
| 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 | MICHELLE GREANEY |
| Manufacturer Street | 2568 BRISTOL CIRCLE OAKVILLE |
| Manufacturer City | ONTARIO, L6H 5S1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L6H 5S1 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 2568 BRISTOL CIRCLE OAKVILLE |
| Manufacturer City | ONTARIO, L6H 5S1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L6H 5S1 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREX HD HEADBOX |
| Generic Name | TREX HD HEADBOX |
| Product Code | GWQ |
| Date Received | 2020-01-31 |
| Model Number | 008043 |
| Catalog Number | 008043 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | DBA EXCEL-TECH LTD. (XLTEK) 2568 BRISTOL CIRCLE OAKVILLE, L6H 5S1 CA L6H 5S1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-31 |