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

Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Paralysis (1997); Sleep Dysfunction (2517); Tics/Tremor (4425)

Event Date 01/31/2023

Event Type  Injury  

Event Description

I got an euflexxa injection in both knees for osteoarthritis.This caused joint and muscle pain, low back pain, severe headache, extreme fatigue, muscle weakness and even leg paralysis for a few hours.I also had insomnia and started having daily shaking episodes, nonepileptic seizures, lasting 30 minutes to 6 hours.I was hospitalized on a neuro unit twice.The 1st time for 2 days and the 2nd time for 4 days.I was also treated in the er twice.I started taking benadryl for the insomnia and the immunologist i saw had me decrease the dose.As i did the shaking episodes occurred daily for weeks.The hospital neurologist said my symptoms cause were a mystery.When i was discharged i increase the benadryl to 50 mg/night and the shaking episodes went away.The outpatient neurologist agreed the timing was right for an allergic reaction to the euflexxa and had me slowly wean off the benadryl.Reference report: #mw5149931.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 18474639
• MDR Text Key: 332657662
• Report Number: MW5149932
• 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: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Patient Sequence Number: 1
• Treatment: CELEBREX 200 MG 1 A DAY. ; CRESTOR 5MG 1 A DAY. ; DOTERRA LIFELONG VITALITY PACK PROBIOTIC.
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White