MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-24 for NICOLET LTM 515-004400F manufactured by Nicolet Ltm.
| Report Number | 3010611950-2020-00007 |
| MDR Report Key | 9873485 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-17 |
| Date Added to Maude | 2020-03-24 |
| 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 | IDA BUSINESS PARK GORT |
| Manufacturer City | CO.GALWAY, H91PD92 |
| Manufacturer Country | EI |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD MIDDLETON |
| Manufacturer City | WISCONSIN, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET LTM |
| Generic Name | NICOLET LTM |
| Product Code | GWQ |
| Date Received | 2020-03-24 |
| Model Number | 515-004400F |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NICOLET LTM |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WISCONSIN, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |