MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-09 for GRASS GENUINE CUP ELECTRODES F-E6GH-48 manufactured by Natus Manufacturing Limited.
[77445999]
Customer has been asked preliminary analysis questions to understand the sequence of the sleeping study and different equipment used that lead to the reported adverse event. Customer confirmed that patient did not have and mri and no defibrillator was used. Electrodes connected to the patient were of the same type. Customer advised that there is no permanent damage expected and there was no hospitalization lengthened due to the burns. Patient is healing well. Further investigation is required to determine possible root cause. Customer has been contacted via email with questionnaire to provide the rest of the required information below. Patient identifier - awaiting customer response. Age at the time of event, date of birth - awaiting customer response. Sex - awaiting customer response. Weight - awaiting customer response. Relevant tests/laboratory data, including dates - awaiting customer response. Other relevant history, including preexisting medical conditions (e. G. , allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc. ) - awaiting customer response. Lot # - awaiting customer response concomitant medical products and therapy dates (excludes treatment of event) - awaiting customer response. Health professional? - awaiting customer response. Occupation - awaiting customer response. Device manufacture date (mm/dd/yyyy) - awaiting customer response to provide lot#. Justification for not providing below information and applicable sections: serial # - this section is not applicable as the medical device does not have serial #. Expiration date (mm/dd/yyyy) - this section is not applicable as the device is reusable. If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient. If ind, give protocol # - this section is not applicable as the medical device is not ind. Adverse event term(s) - this section is not applicable to medical devices. 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).
Patient Sequence No: 1, Text Type: N, H10
[77446000]
Patient with burn spot. Second degree burn was discovered on patient's head and ear after 22 hour study. There was yellow pus in the cap after electrode removal. Locations of the burns coincide with the locations of the electrodes. It wasn't the first use of the electrodes.
Patient Sequence No: 1, Text Type: D, B5
[106069573]
Patient identifier has not been provided as customer considers it confidential.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2017-00006 |
| MDR Report Key | 6629165 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-09 |
| Date of Report | 2017-05-15 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-06-09 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MIA DUDICOVA |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 3539164743 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRASS GENUINE CUP ELECTRODES |
| Generic Name | RECORDING ELECTRODES |
| Product Code | GXY |
| Date Received | 2017-06-09 |
| Returned To Mfg | 2017-06-06 |
| Model Number | F-E6GH-48 |
| Catalog Number | F-E6GH-48 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT, CO. GALWAY H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-09 |