MAUDE Adverse Event Report: EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Cyst(s) (1800); Inflammation (1932); Pain (1994); Reaction, Injection Site (2442)

Event Date 03/23/2018

Event Type  Injury  

Event Description

Doctor prescribed 3 shots of euflexxa.First shot had some ankle pain, after 2nd and 3rd shots had severe knee pain.Doctor prescribed methylprednisolone to get rid of inflammation, came right back.After some research needs to be a bigger waring if you have a baker cyst, knee is worse after the injections.Date the person first started taking or using the product: (b)(6) 2018.Date the person stopped taking or using the product: (b)(6) 2018.Why was the person using the product: knee pain.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 7624709
• MDR Text Key: 112132229
• Report Number: MW5077976
• 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: 06/18/2018

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 110