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 |