MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-05-12 for GRASS F-E2-48 manufactured by Natus Manufacturing Limited.
[44991794]
Customer complained of burns to the skin around electrode following use of grass subdermal needle electrodes. Customer said: "patient had a bifrontal craniotomy for tumor resection with intraoperative mri imaging and intraoperative neurophysiologic monitoring including sseps and mers. The mri was done with the platinum electrodes in place. When the surgical drapes were removed burns were noted at the site of the evoked potential electrodes on the forehead and bilateral chest. There were 2-4mm areas where the skin around the electrode appeared burned".
Patient Sequence No: 1, Text Type: D, B5
[59914695]
The following has been corrected: corrected to (b)(6) 2016 from (b)(6) 2016. Customer has been contacted to provide the rest of the required information. A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information.
Patient Sequence No: 1, Text Type: N, H10
[59983757]
This section is not applicable as the medical device is re-usable therefore no expiry date. If remedial action initiated, check type - this section is not applicable as no remedial action was initiated. If action reported to fda under 21 usc 360i(f), list correction/removal reporting number - this section is not applicable as there was no action reported under 21 usc 360i(f) customer has been contacted to provide the rest of the required information. We are in the process of gathering additional information. A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information. Sections still require information: awaiting customer response.
Patient Sequence No: 1, Text Type: N, H10
[60008140]
Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2016-00003 |
| MDR Report Key | 5649698 |
| Report Source | OTHER |
| Date Received | 2016-05-12 |
| Date of Report | 2016-04-18 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2016-04-18 |
| Device Manufacturer Date | 2015-11-16 |
| Date Added to Maude | 2016-05-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY |
| Manufacturer Country | EI |
| Manufacturer Phone | 091647451 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NOT APPLICABLE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRASS |
| Generic Name | SUBDERMAL NEEDLE ELECTRODE |
| Product Code | GXZ |
| Date Received | 2016-05-12 |
| Model Number | F-E2-48 |
| Catalog Number | F-E2-48 |
| Lot Number | 38471 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT, CO. GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-12 |