MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-15 for DANTEC CONCENTRIC NEEDLE ELECTRODE 9013S0032 manufactured by Natus Manufacturing Limited.
[117290475]
Device history record to be reviewed. Defective part requested to be returned. Further information requested from the customer. Patient information - no patient injury reported, device malfunction occurred. Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury occurred. Suspect products - not applicable. Serial # the medical device does not have a serial number. The medical device is not implantable. The medical device is not a single-use device that was reprocessed or reused on a patient.
Patient Sequence No: 1, Text Type: N, H10
[117290476]
Hub and cannula separation from colour cover during removal of connector cable. "when pulling out the emg needle, the plastic socket will detach at the connection of emg needle to lead cable, thereby uncontrollable needle movement and risk of injury to users. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00007 |
| MDR Report Key | 7784042 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-15 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-07-02 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2017-07-05 |
| Date Added to Maude | 2018-08-15 |
| 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 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 | DANTEC DISPOSABLE CONCENTRIC NEEDLE |
| Product Code | IKT |
| Date Received | 2018-08-15 |
| Returned To Mfg | 2018-08-15 |
| Model Number | 9013S0032 |
| Catalog Number | 9013S0032 |
| Lot Number | 27B/17/D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-15 |