MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-07-18 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0042 manufactured by Natus Manufacturing Ltd.
| Report Number | 3005581270-2019-00011 |
| MDR Report Key | 8801571 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-07-18 |
| Date of Report | 2019-09-12 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 2017-11-23 |
| Date Added to Maude | 2019-07-18 |
| 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 | NATUS MANUFACTURING LTD |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, 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 NEEDLE ELECTRODE |
| Generic Name | DANTEC DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2019-07-18 |
| Model Number | 9013S0042 |
| Catalog Number | 9013S0042 |
| Lot Number | 47F/17/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, H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-18 |