MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for SPENCER PROBE ELECTRODE RD10R-SPO5X-000 manufactured by Ad-tech Medical Instrument Corp..
[39097415]
Patient Sequence No: 1, Text Type: N, H10
[39097416]
"patient admitted for eeg monitoring via grid. Upon assessment, it was noted that electrodes on the outside of the body had wires protruding out of rubber covering. This was discovered after eeg monitoring had been discontinued. Neurosurgery, notified of protruding wires. " 3mm, 5mm, and 7mm electrodes were used. None of the electrodes or packages were saved from surgery. The product number for the 5mm is rd10r-sp05x-000 and the 7mm is rd10r-sp07x-000. The ref number for the 3mm is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5462719 |
| MDR Report Key | 5462719 |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-18 |
| Date of Event | 2016-02-15 |
| Report Date | 2016-02-18 |
| Date Reported to FDA | 2016-02-18 |
| Date Reported to Mfgr | 2016-02-18 |
| Date Added to Maude | 2016-02-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPENCER PROBE ELECTRODE |
| Generic Name | ELECTRODE, DEPTH |
| Product Code | GZL |
| Date Received | 2016-02-26 |
| Catalog Number | RD10R-SPO5X-000 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM ST RACINE, WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-26 |