HYLATOPICPLUS CREAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for HYLATOPICPLUS CREAM manufactured by Precision Dermatology.

Event Text Entries

[72122540] Other serious/important medical incident: burned facial and neck skin. I have suffered from eczema for many years. On about (b)(6) my dermatologist prescribed hylatopic plus cream for me. I used it on my face and forehead, and on my neck. I only used it two times, because my face became very red and irritated. Today, more than two weeks later, my skin is still red, itchy - and it is as if my skin is burned on my forehead, near my eyes, my cheeks, and my entire neck. After using, i reread the "precautions and observations," to again see that it says that the product does not contain sunscreen and to avoid extended exposure to the sun. I was in the sun for no more than 10 minutes after putting this cream on. The few minutes i was out in the sun, i had a baseball cap on, and the top portion of my forehead did not get burned. The lower part of my forehead, below where protected by the hat - got burned, along with the rest of my face and neck. My skin which was not exposed because of my shirt - is fine. I am very concerned that my face is still red - like a burn this much time after using the cream. My dermatologist thinks it is eczema, but this is not eczema - it is a burn. It is manufactured for encore derm. Ndc number: (b)(4). Frequency: 3 times a day. Date the person stopped taking or using the product: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068934
MDR Report Key6463363
Date Received2017-04-03
Date of Report2017-04-02
Date of Event2017-03-15
Date Added to Maude2017-04-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHYLATOPICPLUS CREAM
Generic NameHYLATOPICPLUS CREAM
Product CodeMGQ
Date Received2017-04-03
Device Expiration Date2018-09-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPRECISION DERMATOLOGY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.