MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SODIUM HYALURONATE

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Fatigue (1849); Inflammation (1932); Nausea (1970); Pain (1994); Swelling (2091); Tachycardia (2095); Arthralgia (2355); Ambulation Difficulties (2544)

Event Date 11/08/2017

Event Type  Injury  

Event Description

I received my last of three weekly injections of euflexxa in my left knee beginning (b)(6) 2017 and ending (b)(6) 2017.Each injection brought on multiple negative side effects.These side effects included: immediate swelling of the left calf muscle.Joint pain on the left side of my body, up to and including my left wrist and muscle ache in the left forearm.Inability to walk for 3-4 days following each injection due to severe knee pain.Nausea.Fatigue and flu-like symptoms.Extremely red face and facial puffiness approx 15 minutes post injection.Racing / pounding heartbeat approx 5-10 minutes post injection and persisting approx 1-2 hours.In summation, the injections have made me ill, and have reduced my ambulatory capacity.I did inform my physician after the first injection.I was not advised to discontinue the series of injections.Now i am advised that due to the injections, knee surgery cannot even be discussed for two and one-half months to three months due to increased risk on infection because of the injections.I remain totally disabled and will not allow myself to be subject to treatment with euflexxa, or similar injections in future.Thank you for collecting data on this medication type.Dates of use: (b)(6) 2017."did the problem stop after the person reduced the dose or stopped taking or using the product: yes, did the problem return if the person started taking or using the product again: yes.Osteo arthritis left knee.

• Brand Name: EUFLEXXA 1% SODIUM HYALURONATE
• Type of Device: EUFLEXXA 1% SODIUM HYALURONATE
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 7041028
• MDR Text Key: 92527281
• Report Number: MW5073407
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Weight: 99