MAUDE Adverse Event Report: FERRING PHARMACEUTICALS, INC. EUFLEXXA INJ 10MG/ML; ACID, HYALURONIC

Device Problem Insufficient Information (3190)

Patient Problems Sjogren's Syndrome (2073); Urticaria (2278)

Event Date 06/20/2018

Event Type  Injury  

Event Description

Pt stated she has received a series of euflexxa injections twice.The first time she didn't have any problems.She stated about six weeks after the second series that she received starting in (b)(6) 2017 she developed hives.Pt also has sjogren's syndrome, which she doesn't believe has anything to do with the hives.

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: ACID, HYALURONIC
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC.
• MDR Report Key: 7637693
• MDR Text Key: 112485794
• Report Number: MW5078033
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR