MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-12-09 for ELEFIX manufactured by Nihon Kohden Corp..
[18259697]
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 (b)(6) 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. Imp ref#: 2080783-2014-00088.
Patient Sequence No: 1, Text Type: D, B5
[18464700]
Our ts called to check the status of the patient, but the person at the (b)(6) stated that the patient had left for the emergency room after flushing his eyes with water. Followed up on monday, patient stated he went to the er nearby and he stated that the elefix caused a mild chemical burn and gave him conjunctivitis. They flushed his eyes our and gave him drops. At the time of this call, the patient also stated that he rubbed his eyes when he was getting his eeg procedure at (b)(6) and that is when he got the paste in his eyes. He stated that the lab staff did nothing to help him, and they did not remove the elefix from his head before he left the lab.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030229-2014-00088 |
| MDR Report Key | 4375211 |
| Report Source | 04 |
| Date Received | 2014-12-09 |
| Date Mfgr Received | 2014-11-26 |
| Date Added to Maude | 2015-01-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1-31-4 NISHIOCHIA, SHINJUKU-KU |
| Manufacturer City | TOKYO 161-8560 |
| Manufacturer Country | JA |
| Manufacturer Postal | 161-8560 |
| Manufacturer Phone | 7050350 |
| Single Use | 3 |
| 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 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-09 |