MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-11-23 for GRASS ELECTRODES FS-E5GH-60 manufactured by Natus Manufacturing Limited.
[60843352]
Dhr was obtained and reviewed. All manufacturing work steps have been completed and signed for as per route card. In process test form for grass electrodes was reviewed. All tests were completed and signed off. No failures recorded. 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.
Patient Sequence No: 1, Text Type: N, H10
[60843353]
Recently customer noted that where the electrodes are, when taking them off, there are wounds! (sounds like blisters from chemical reaction). Also the inside of the electrodes discolor, without the coating being damaged.
Patient Sequence No: 1, Text Type: D, B5
[71591874]
No issues with the production of this lot of electrodes. The device was found to have met specifications prior to shipment. No manufacturing anomalies were identified that may have caused or contributed to the reported event. This is the first event reported for this lot number to date. The result of the investigation is inconclusive as the device was not returned for evaluation. It has been reported that the device caused wounds/blisters. Based upon the available information a definitive root cause cannot be determined. It is unknown whether patient factors or cleaning/disinfecting process may have contributed to the reported event. Questionnaires sent to the customer to get more information in relation to how electrodes were cleaned and sterilised prior to use. Customer has been contacted on three occasions with a letter listing remaining required information below in order to submit the follow up report. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient and product details. (b)(4). Corrections: initial reporter should reference the healthcare facility that reported the adverse event to the manufacturer. (b)(4) would like to correct this section from the initial report 3005581270-2016-00010 to the following: (b)(6). Device manufacture date (mm/dd/yyyy) - information in the initial report ''his section is not applicable as manufacturer do not specify the device manufacture date'' has been provided incorrectly. (b)(4) would like to correct this section from the initial report 3005581270-2016-00010 to the following: device manufacture date is 02/22/2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2016-00010 |
| MDR Report Key | 6126503 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-11-23 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-06-20 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2016-02-22 |
| Date Added to Maude | 2016-11-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO.GALWAY H91PD92, |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92, |
| Manufacturer Phone | 3539164740 |
| 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 ELECTRODES |
| Generic Name | GRASS GENUINE CUP ELECTRODES |
| Product Code | GXY |
| Date Received | 2016-11-23 |
| Model Number | FS-E5GH-60 |
| Catalog Number | FS-E5GH-60 |
| Lot Number | 48514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-11-23 |