MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-11 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0012 manufactured by Natus Manufacturing Ltd..
[130616010]
Work order has been obtained and will be reviewed. Defect parts have been requested to be returned. Customer informed natus that they will be returning 11 boxes of needles of the same lot number and the cable used. It is unknown if the defect needle is being returned from the customer at this time. Justification for not providing below information and applicable sections: no patient injury reported, device malfunction occurred. Date of event - this information was requested from the customer and waiting for a response.
Patient Sequence No: 1, Text Type: N, H10
[130616011]
Faulty product: 9013s0012 lot 25b/18/d: needle issue. Hub separation occurred. This event did not result in a needle stick to the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00015 |
| MDR Report Key | 8150010 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-11 |
| Date of Report | 2019-02-05 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2018-06-20 |
| Date Added to Maude | 2018-12-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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, 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 | DANTEC DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2018-12-11 |
| Returned To Mfg | 2018-12-11 |
| Model Number | 9013S0012 |
| Catalog Number | 9013S0012 |
| Lot Number | 25B/18/D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LTD. |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91 PD92 EI H91 PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-11 |