FDA Adverse Event
Other
Summary report: N
EPICERAM SKIN BARRIER EMULSION
MDR report key: 1622864
·
Received March 1, 2010
Report
- Report Number
- 3006279883-2010-00003
- Event Type
- Other
- Date Received
- March 1, 2010
- Report Date
- January 14, 2010
- Manufacturer
- CERAGENIX PHARMACEUTICALS, INC.
- Product Code
- FRO
- PMA / PMN Number
- K052643
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CERAGENIX IS PROVIDING THIS INFO TO ADDRESS THE PHYSICIAN REQUEST ALTHOUGH THE PHYSICIAN CONFIRMED AND STATED THAT, PER THEIR MEDICAL OPINION, THIS EVENT WOULD NOT HAVE CAUSED PERMANENT DAMAGE OR INJURY WITH OR WITHOUT TREATMENT.
Description of Event or Problem · 1
REPORT RECEIVED FROM DISTRIBUTOR (B)(6) 2010. THE PT, HAVING BEEN PRESCRIBED EPICERAM FOR AN UNK FACIAL ISSUE, DEVELOPED AN ALLERGIC CONTACT DERMATITIS. THE PHYSICIAN CONTACTED INDICATED THE PT WAS TREATED WITH AN UNK STEROID, UNK DOSAGE OR STRENGTH. THE PHYSICIAN INDICATED THAT EVEN WITHOUT TREATMENT WITH A STEROID, THIS EVENT WOULD NOT HAVE RESULTED IN PERMANENT INJURY OR ILLNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPICERAM SKIN BARRIER EMULSION | NONE | FRO | CERAGENIX PHARMACEUTICALS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PHYSICIAN DID NOT INDICATE OTHER PRODUCTS IN USE. |