MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-06 for CORKSCREW ELECTRODE 1.2M LEAD 017505 manufactured by Natus Neurology, Incorporated.
[101857103]
(b)(4). Customer is inconsistent on reporting frequency of incident. Customer no longer has any remaining electrodes and does not wish to further pursue complaint.
Patient Sequence No: 1, Text Type: N, H10
[101857104]
Corkscrew electrode broke during patient testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2018-00002 |
| MDR Report Key | 7318597 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-06 |
| Date of Report | 2018-02-07 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2018-03-06 |
| 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 | 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 | CORKSCREW ELECTRODE 1.2M LEAD |
| Generic Name | CORK SCREW ELECTRODE |
| Product Code | GXZ |
| Date Received | 2018-03-06 |
| Model Number | 017505 |
| Catalog Number | 017505 |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE 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 | 2018-03-06 |