MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-04 for SUBDURAL ELECTRODE TS06RSP10X000 manufactured by Ad-tech Med Instrument Corp.
[4276831]
Two surgeons removed 8 strip electrodes at bedside and noted that in 2 of the 8 strip electrodes some electrode discs separated from the electrode strips as they were being pulled through the skin. This is an unexpected occurrence. The other 6 electrodes were removed in the usual fashion without any problems and were intact. The separated discs were accounted for and there was no injury to the pt. A skull x-ray was done after the procedure which confirmed that there were no retained electrode parts. Diagnosis or reason for use: implanted for eeg monitoring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035532 |
| MDR Report Key | 3736502 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-04-03 |
| Date of Event | 2014-03-28 |
| Date Added to Maude | 2014-04-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBDURAL ELECTRODE |
| Generic Name | SUBDURAL ELECTRODE |
| Product Code | GYC |
| Date Received | 2014-04-04 |
| Model Number | TS06RSP10X000 |
| Lot Number | 208140528 |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MED INSTRUMENT CORP |
| Manufacturer Address | RACINE WI 53401 US 53401 |
| Brand Name | SUBDURAL ELECTRODE |
| Generic Name | SUBDURAL ELECTRODE |
| Product Code | GYC |
| Date Received | 2014-04-04 |
| Model Number | TS06RSP10X000 |
| Lot Number | 208140535 |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MED INSTRUMENT CORP |
| Manufacturer Address | RACINE WI 53401 US 53401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-04 |