MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Burning Sensation (2146)

Event Date 11/01/2017

Event Type  Injury  

Event Description

Please send me an email address, as i would like to send you pictures of my reaction to a euflexxa shot.I had one shot of euflexxa last wednesday, and my knee broke out in 3 areas around the injection.I had burning and itching over the past week.After taking benadryl for several days, there was not much improvement."have you seen this happen before, what do you suggest." thank you.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017."did the problem stop after the person reduced the does or stopped taking or using the product: yes." knee osteoarthritis.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING PHARMACEUTICALS
• MDR Report Key: 7024673
• MDR Text Key: 91918189
• Report Number: MW5073259
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 11/07/2017

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 101