MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-25 for ELEFIX manufactured by Nihon Kohden.
[2514834]
Ismp medication errors reporting program. Description: a child with an egg allergy was admitted to our hospital for a 36h video eeg. Towards the end of the eeg, the child started breaking out in hives. He did not have respiratory difficulties or anaphylaxis. The eeg was stopped, paste was removed, and the child was given diphenhydramine. The child's grandmother noted that the eeg paste (elefix made by nihon kohden) said (i don't know the wording exactly) not for use in egg allergic pts. Our facility was not aware of this and we have since implemented a checklist prior to application of the paste in all pts getting an eeg. Pt's gender: unknown. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024001 |
| MDR Report Key | 2431073 |
| Date Received | 2012-01-25 |
| Date of Report | 2011-12-27 |
| Date of Event | 2011-01-01 |
| Date Added to Maude | 2012-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEFIX |
| Generic Name | EEG PASTE |
| Product Code | GYB |
| Date Received | 2012-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-01-25 |