MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-12-09 for ELEFIX manufactured by Nihon Kohden Corp.
[5117114]
Friday, patient (b)(6) called our company after being treated at (b)(6) for an eeg procedure. He touched his head and got elefix paste in his eye. Ron stated that now his "vision is 10% hazy". Our technical support (ts) read our msds sheet to him. "eye contact: flush affected areas thoroughly with water. If irritation develops, consult a physician". The patient stated that he only used imitation tears in his eyes. He was going to flush his eyes with water and if this does not resolve the hazy vision he will go to the emergency room. Our ts advised him to go back to the va where his procedure was done, but the patient stated that it was too far from the (b)(6) that he resides at and does not have a way to get there till the following monday. Mfr ref#: 8030229-2014-00088.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2080783-2014-00088 |
| MDR Report Key | 4375213 |
| Report Source | 99 |
| Date Received | 2014-12-09 |
| Date of Report | 2014-11-21 |
| Date of Event | 2014-11-21 |
| Date Facility Aware | 2014-11-21 |
| Report Date | 2014-11-21 |
| Date Reported to Mfgr | 2014-11-26 |
| Date Added to Maude | 2015-01-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 90 ICON ST. |
| Manufacturer City | FOOTHILL RANCH CA 926101601 |
| Manufacturer Country | US |
| Manufacturer Postal | 926101601 |
| Manufacturer G1 | NIHON KOHDEN AMERICA, INC. |
| Manufacturer Street | 90 ICON ST. |
| Manufacturer City | FOOTHILL RANCH CA 92610160 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92610 1601 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEFIX |
| Generic Name | ELEFIX ELECTRODE CREAM |
| Product Code | GYB |
| Date Received | 2014-12-09 |
| Model Number | ELEFIX |
| Catalog Number | ELEFIX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-09 |