MAUDE Adverse Event Report: FERRING PHARM. INC. EUFLEXXA SODIUM HYALURONATE; EUFLEXXA SODIUM HYALURONATE

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Headache (1880); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Muscular Rigidity (1968); Pain (1994); Rash (2033); Urticaria (2278); Sore Throat (2396)

Event Date 06/25/2013

Event Type  Injury  

Event Description

A few days after receiving euflexxa injections to bilateral knees, i noticed itching in both ears and on both elbows.The skin on my elbows became psoriasis in nature.On (b)(6) 2013 11:00 am i received the 2nd injection of the euflexxa series in bilateral knees by my orthopedic doctor.At approx.12:30 i began to have generalized itching.I took a benadryl (generic) 25mg.Itching continued to increase.At approx.5 pm i noticed a blotchy rash on my upper arms, abdomen, back and thighs.That evening the rash began to appear more as red raised hives.My fingertips became very tender as if rubbed on a rough surface and my hands became sensitive to warm water.Joints on my left hand became stiff and sore with movement.The pain began to increase and became severe in almost all of my joints.It radiated from joint to joint becoming so severe in my hand and wrist that i thought i might need to go to the emergency room, but i didn't want to move because the pain was so excruciating.I developed a severe sore throat, had a headache and low grade fever.No redness was ever noted at the injection sites.That radiating joint pain continued over the next several days although not as severe.I saw the orthopedic doctor on (b)(6) 2013 was given a medrol dose pack and refused any final injections in the euflexxa series.He prescribed a medrol dose pack, which i filled and took until finished.I saw my pmd on (b)(6) 2013 instructed to take an antihistamine which i was already taking and pepcid.I had labs drawn on this day also.I was also advised to see an allergist which i saw on (b)(6) 2013 since i continued with itching and rash.I was given triamcinolone cream 0.1% and told to take claritin and pepcid everyday, which i started taking.I needed to take the claritin and pepcid to the end of (b)(6).When i tried to stop it, the itching returned, mostly noted in eyes, face and ears.During this entire episode i had to use special shampoo due to the itching and i also became sensitive to several foods with itching and rash increasing.Now that has subsided.I never had any allergies prior to this.Needed md follow up and also had to see allergist.Strength: questionably 1 cc each syringe.Quantity: 1 injection each knee.Date the person first started taking or using the product: on (b)(6) 2013.Date the person stopped taking or using the product: on (b)(6) 2013.Why was the person using the product: osteoarthritis bilateral knees.I was giving synvisc rt knee in 2011.

• Brand Name: EUFLEXXA SODIUM HYALURONATE
• Type of Device: EUFLEXXA SODIUM HYALURONATE
• Manufacturer (Section D): FERRING PHARM. INC.
• MDR Report Key: 3727725
• MDR Text Key: 4328177
• Report Number: MW5035454
• 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: Patient
• Type of Report: Initial
• Report Date: 03/26/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: 1ST DOSE G16436A 2ND DOSE G164
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: METOPROLOL; LEVOTHVROXINE
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 98