MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Ambulation Difficulties (2544)

Event Date 05/18/2020

Event Type  Injury  

Event Description

Adverse effect from euflexxa; i had two injections over a two weeks period of euflexxa.It was injected into my left knee to treat oa.I was in mild pain before the shots and was able to walk and stand for the majority of my days.I received the first shot on (b)(6) 2020 along with a shot of cortisone and seemed to tolerate it well.I received the second shot on (b)(6) 2020 and within 48 hours my knee was swollen the size of a cantaloupe.I could not put my weight on it or walk on it.I had a migraine and severe back pain and spasms.I believed that i was suffering from systemic inflammation.I was seen by my doctor on (b)(6) 2020 and had fluid drained from knee.I also went to the emergency room on (b)(6) 2020 and was prescribed prednisone for 9 days.Now 17 days later i am wearing a knee brace constantly and still experiencing extreme pain.I am scheduled for an mri on (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC
• MDR Report Key: 10132740
• MDR Text Key: 194668128
• Report Number: MW5094888
• Device Sequence Number: 2
• 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: 06/04/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 75