MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-24 for DANTEC KEYPOINT G4 9031E0722-R manufactured by Natus Manufacturing Ltd.
| Report Number | 3005581270-2019-00012 |
| MDR Report Key | 9109347 |
| Date Received | 2019-09-24 |
| Date of Report | 2019-10-21 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2019-09-05 |
| Date Added to Maude | 2019-09-24 |
| 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 | MISS LOUISE CALLANAN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | PAUL E. DANCHELL A/S, |
| Manufacturer Street | LYNGVEJ 8, 4450 JYDERUP, |
| Manufacturer Country | DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DANTEC KEYPOINT G4 |
| Generic Name | MULTI STIM FOR G4 |
| Product Code | GWF |
| Date Received | 2019-09-24 |
| Model Number | 9031E0722-R |
| Catalog Number | 9031E0722-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LTD |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-24 |