MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-02 for EPICERAM SKIN BARRIER EMULSION manufactured by Promius Pharma.
[1522160]
My son's doctor prescribed the use of "epi-ceram" to be applied all over his skin in order to alleviate his eczema. After several days of application, my son was covered in contact dermatitis, caused by an allergy to the "epi-ceram". Dose or amount: applied to skin all over, frequency: once per day, route: top. Dates of use: (b) (6) 2010 - (b) (6) 2010. Diagnosis or reason for use: eczema. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015465 |
| MDR Report Key | 1653587 |
| Date Received | 2010-04-02 |
| Date of Report | 2010-04-02 |
| Date of Event | 2010-03-26 |
| Date Added to Maude | 2010-04-13 |
| 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 | 3 |
| 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 |
| Generic Name | EPICERAM SKIN BARRIER EMULSION |
| Product Code | MGQ |
| Date Received | 2010-04-02 |
| Lot Number | 25344177 |
| ID Number | 67857-800-90 |
| Device Expiration Date | 2011-06-30 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROMIUS PHARMA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-02 |