MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for HYLATOPIC PLUS CREAM manufactured by Encore.
[72739881]
Patient reported rash on face, which is where medication was applied. Stopped medication for 1 week with no improvement. Frequency: daily. Route: topical. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2017. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069018 |
| MDR Report Key | 6485385 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-02-07 |
| Date of Event | 2017-01-30 |
| Date Added to Maude | 2017-04-12 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYLATOPIC PLUS CREAM |
| Generic Name | HYLATOPIC PLUS CREAM |
| Product Code | MGQ |
| Date Received | 2017-04-12 |
| Lot Number | 6090 |
| Device Expiration Date | 2018-07-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCORE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |