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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Swelling (2091); Cramp(s) (2193); Reaction (2414); Lethargy (2560)

Event Date 10/08/2016

Event Type  Injury  

Event Description

I have been using synvisc with no problem, kept me working, insurance change, they wanted euflexxa.First injection severe stomach cramps, 2nd injection, anaphylactic reaction, fever, rash, severe lethargy, headache, swelling in all joints.Flu like symptoms, neck pain, memory problems, knees hurt worse.Didn't work and refused 3rd set of injections.Had trouble breathing.Reason for use: knee pain.How was it taken or used: intra-articular.Date the person first started taking or using the product: (b)(6) 2016.Date the person stopped taking or using the product: (b)(6) 2016.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 6043148
• MDR Text Key: 58053345
• Report Number: MW5065512
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADDERALL; COQ10; EXCEDRIN MIGRAINE; FISH OIL; FOLIC ACID; LORTAB; LOSARTAN; MAGNESIUM; METHOCARBAMOL; MULTI VITAMIN; NAPROXEN; NIACIN; PANTOPRAZOLE; PREDNISONE; VITAMIN B12; VITAMIN C; VITAMIN D3; VITAMIN E; XANAX; ZYRTEC
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 55 YR
• Patient Weight: 87