MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-09-28 for CUSTOM MEDICAL ELECTRODE CME-6PX-F372 manufactured by Ad-tech Medical Instrument Corp..
[2970848]
Patient received about 1cm * 1cm several millimeter deep injury in the temporal cortex from the edge (corner? ) of the customer electrode on one side. Surgeon noticed stiffness at implantation. It seemed to be both sharp corners, sharp edges and stiff/firm plastic. The doctor reported there was no serious injury believed to be life threatening even if temporary in nature or a serious injury that would result in permanent impairment of a body function or permanent damage to a body structure. The damage was taken care of during the procedure. The doctor reported that the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[10275102]
This was a custom electrode. Ad-tech does not stock these devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2012-00011 |
| MDR Report Key | 2768738 |
| Report Source | 01,08 |
| Date Received | 2012-09-28 |
| Date of Report | 2012-09-26 |
| Date Mfgr Received | 2012-08-29 |
| Device Manufacturer Date | 2012-08-07 |
| Date Added to Maude | 2012-10-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LISA THEAMA |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM MEDICAL ELECTRODE |
| Generic Name | CUSTOM ELECTRODE |
| Product Code | GYC |
| Date Received | 2012-09-28 |
| Catalog Number | CME-6PX-F372 |
| Lot Number | 208140477 |
| ID Number | BATCH NUMBER: 64815 |
| Device Expiration Date | 2013-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-28 |