MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-13 for NATUS GOLD CUP ELECTRODES 019-477500 manufactured by Natus Neurology, Incorporated.
[77499315]
Registered internally as complaint (b)(4), for further investigation by manufacturer. The attending physician indicated that patients were sent home with a balm called flamigel the complaint came to natus (b)(4) as a result of another natus sister facility complaint. The customer completed a questionnaire stating they were seeing skin irritation after eeg monitoring. The customer added (b)(4) part 019477500 to the questionnaire response. We have reached out to the customer on three additional occasions to ask for information and have not received a response. The customer is located in the netherlands. The customer did indicate in the original questionnaire that certain glues and removers were used on the patients, but did not indicate what was being used between the electrode and skin as a conductive, which often impacts skin irritation.
Patient Sequence No: 1, Text Type: N, H10
[77499316]
Electrode size wounds are sometimes found after removing eeg-monitoring electrodes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2017-00001 |
| MDR Report Key | 6638525 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-13 |
| Date of Report | 2017-05-11 |
| Date of Event | 2016-06-20 |
| Date Mfgr Received | 2017-05-12 |
| Date Added to Maude | 2017-06-13 |
| 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. JANESSA BOONE |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298603 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATUS GOLD CUP ELECTRODES |
| Generic Name | NATUS GOLD CUP ELECTRODES |
| Product Code | GXY |
| Date Received | 2017-06-13 |
| Model Number | 019-477500 |
| Catalog Number | 019-477500 |
| Lot Number | 027826 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY, INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-13 |