MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for AVO CREAM TOPICAL EMULSION manufactured by .
[4942599]
(b)(6). I'm reporting a product packaging concern. The product avo cream topical emulsion contains no listing of ingredients on the inner or outer packaging. The packaging refers to user to the product info insert. The lack of ingredients is problematic in a health care setting because the tube is often removed from the box. No error specifically occurred for this report, but this could be an opportunity for errors to occur in the future. Medication administered to or used by the pt: no. (b)(6) medication errors reporting program.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038311 |
| MDR Report Key | 4114693 |
| Date Received | 2014-09-16 |
| Date of Event | 2014-07-25 |
| Date Added to Maude | 2014-09-25 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVO CREAM TOPICAL EMULSION |
| Generic Name | AVO CREAM TOPICAL EMULSION |
| Product Code | MGQ |
| Date Received | 2014-09-16 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-16 |