MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-10-01 for DANTEC CONCENTRIC NEEDLES 9013S0012 manufactured by Natus Manufacturing Ltd..
| Report Number | 3005581270-2019-00013 |
| MDR Report Key | 9140432 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-10-01 |
| Date of Report | 2019-11-22 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2019-10-01 |
| 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 | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNACHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MANUFACTURING LTD |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNACTH H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DANTEC CONCENTRIC NEEDLES |
| Generic Name | ELECTROMYOGRAPHIC NEEDLE ELECTRODE, SINGLE-USE |
| Product Code | IKT |
| Date Received | 2019-10-01 |
| Model Number | 9013S0012 |
| Catalog Number | 9013S0012 |
| Lot Number | 21B/18/D |
| 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, CONNACHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-01 |