MAUDE Adverse Event Report: ENCORE HYLATOPIC PLUS CREAM

Lot Number 6090

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 01/30/2017

Event Type  Injury  

Event Description

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.

• Brand Name: HYLATOPIC PLUS CREAM
• Type of Device: HYLATOPIC PLUS CREAM
• Manufacturer (Section D): ENCORE
• MDR Report Key: 6485385
• MDR Text Key: 72739881
• Report Number: MW5069018
• Device Sequence Number: 1
• Product Code: MGQ
• UDI-Device Identifier: 69482021616
• UDI-Public: 69482-0216-16
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Lot Number: 6090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR