MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-07 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0012 manufactured by Natus Manufacturing Limited.
Report Number | 3005581270-2019-00008 |
MDR Report Key | 8678176 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-06-07 |
Date of Report | 2019-08-02 |
Date of Event | 2019-04-24 |
Date Mfgr Received | 2019-06-05 |
Device Manufacturer Date | 2018-11-08 |
Date Added to Maude | 2019-06-07 |
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 |
Reporter Occupation | PHARMACIST |
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 LIMITED |
Manufacturer Street | IDA BUSINESS PARK GORT |
Manufacturer City | GALWAY, CONNAUGHT 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 | DANTREC DISPOSABLE CONCENTRIC NEEDLE, |
Product Code | IKT |
Date Received | 2019-06-07 |
Model Number | 9013S0012 |
Catalog Number | 9013S0012 |
Lot Number | 45C/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 LIMITED |
Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, H91PD92 EI H91PD92 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-06-07 |