MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-08 for HYLATOPIC PLUS * *16781-216-16 manufactured by Onset Dermatologics.
[5249109]
My husband put hylatopicplus cream on our (b)(6) year old. When we woke up, he had hives on his limbs and face. Severe itchy rash on limbs and face. He was given 1. 5 tsp of hydroxyzine. The rash worsened throughout the day. His allergist called in a prescription for a steroid. Dose or amount: rub on skin, frequency: once daily. Dates of use: (b)(6) 2014. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039563 |
| MDR Report Key | 4330452 |
| Date Received | 2014-12-08 |
| Date of Report | 2014-12-08 |
| Date of Event | 2014-12-08 |
| Date Added to Maude | 2014-12-16 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYLATOPIC PLUS |
| Generic Name | HYLATOPIC PLUS |
| Product Code | MGQ |
| Date Received | 2014-12-08 |
| Model Number | * |
| Catalog Number | *16781-216-16 |
| Lot Number | P2160614 |
| ID Number | 16781-216-16 |
| Device Expiration Date | 2016-01-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ONSET DERMATOLOGICS |
| Manufacturer Address | * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-08 |