MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for EPICERAM manufactured by Primus Pharmaceuticals, Inc..
[183103221]
Epi ceram first use friday pm (b)(6) 2020, woke up saturday, red, blisters on skin and pain. It is now (b)(6) 2020, i still have redness and a peeling face. Called dermatologist. Receptionist would not let me see the doc and told me to go the nearest emergency room or she will get doc to prescribe me another cream. I asked about cerave and she told me to use that one. I could not use anything for a week or so-too much pain. Then added cerave, it calmed it down some. But, i still have redness on part of face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093643 |
| MDR Report Key | 9810963 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-17 |
| Date Added to Maude | 2020-03-10 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICERAM |
| Generic Name | DRESSING WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-03-09 |
| Lot Number | 64474 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIMUS PHARMACEUTICALS, INC. |
| Product Code | --- |
| Date Received | 2020-03-09 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |