MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Date 03/09/2017

Event Type  Injury  

Event Description

After my first injection of euflexxa on (b)(6) 2017, i noticed more swelling in my knee after a few days.After the 2nd injection of euflexxa on (b)(6) 2017, the swelling in my knee was worse.After the third injection of euflexxa the swelling remained as bad as after the second injection, and the pain continued to be severe.The swelling began to go down after two weeks somewhat, and by (b)(6) 2017 the swelling was reduced by 75 percent.I used ice on my knee daily during the aforementioned time period to help reduce swelling of the tissue around the knee.I did not see where the injections helped me at all.In fact the injections made my knee pain worse, and did not help me in walking any better.Quantity: 1 injection, frequency: 3, intramuscular.Dates of use: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Post surgical severe right knee pain and swelling.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• Manufacturer (Section D): FERRING PHARMACEUTICALS
• MDR Report Key: 6538027
• MDR Text Key: 74292150
• Report Number: MW5069479
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2017
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B12; CALCIUM ; CYMBALTA 60 MG; FUROSEMIDE 20 MG; GUIAFENESEN 600 MG; LEVOTHYROXINE 50 MCG; LOSARTAN 100 MG; MAGNESIUM; MELATONIN 3 MG; NORTRIPTYLINE 50 MG; POTASSIUM KTABS 10 MEQ; SIMVASTATIN 10 MG; TIZANIDINE; TRAMADOL 50MG; TYLENOL 500 MG; VIT D
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 73