HYLATOPIC PLUS CREAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for HYLATOPIC PLUS CREAM manufactured by Encore.

Event Text Entries

[73057415] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069128
MDR Report Key6498166
Date Received2017-02-08
Date of Report2017-02-07
Date of Event2017-01-30
Date Added to Maude2017-04-17
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 NameHYLATOPIC PLUS CREAM
Generic NameHYLATOPIC PLUS CREAM
Product CodeMGQ
Date Received2017-02-08
Lot Number6090
Device Expiration Date2018-07-31
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerENCORE


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-08

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