MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-11 for SUBDURAL ELECTRODE UNK manufactured by Ad-tech Medical Instrument Corporation.
[18545633]
Dr. (b)(6) called to notify ad-tech of an incident at his hospital. He had implanted several "ts" style strips approximately 4 weeks ago. He stated he had removed them, bedside, without incident shortly after. It was just discovered as the patient had returned for an additional wada test and scans that 2 electrodes had been left behind. Unfortunately, since this procedure took place 4 weeks ago, the strips were not kept. In addition, several sizes of out "ts" strips were used and dr. (b)(6) is unable to confirm what size the electrodes are from dr. (b)(6) stated he has been removing these strips bedside 20 years now, without any incident. His hospital has looked into the root cause and can confirm he had been using out platinum strips.
Patient Sequence No: 1, Text Type: D, B5
[18710642]
The reported incident indicates the electrode were removed at the bedside. This removal likely was through the burr hole. The electrode may not have been removed surgically, as indicated in the electrode directions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2014-00001 |
| MDR Report Key | 3938146 |
| Report Source | 05 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-03-11 |
| Date of Event | 2014-01-11 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2014-07-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 534041876 |
| Manufacturer Country | US |
| Manufacturer Postal | 534041876 |
| Manufacturer Phone | 6088772635 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBDURAL ELECTRODE |
| Generic Name | SUBDURAL ELECTRODE |
| Product Code | GYC |
| Date Received | 2014-03-11 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 CORPORATION |
| Manufacturer Address | RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-11 |