MAUDE Adverse Event Report: EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Myalgia (2238); Arthralgia (2355); Shaking/Tremors (2515); Sleep Dysfunction (2517); Convulsion/Seizure (4406)

Event Date 01/31/2023

Event Type  Injury  

Event Description

Severe headache [headache].Extreme fatigue [fatigue].Muscle weakness [muscular weakness].Leg paralysis [monoplegia].Insomnia [insomnia].Daily shaking episodes [tremor].Non-epileptic seizure [seizure].Allergic reaction to the euflexxa [hypersensitivity].Joint pain and muscle pain [myalgia].Joint pain and muscle pain [arthralgia].Low back pain [back pain].Case narrative: this is a serious spontaneous case received from consumer via a regulatory authority in the united states.This report concerns a patient of unknown age and gender who experienced allergic reaction, joint pain, muscle pain, low back pain, severe headache, extreme fatigue, muscle weakness, leg paralysis, insomnia, daily shaking episodes, non-epileptic seizures during treatment with intraarticular euflexxa (sodium hyaluronate) solution for injection, unknown concentration and frequency, 1 dose in both knees, for osteoarthritis from an unknown start date to an unknown stop date.On (b)(6) 2023, after the one euflexxa injections in both knees, the patient experienced joint and muscle pain, low back pain, severe headache, extreme fatigue, muscle weakness, and leg paralysis for a few hours.Additionally, the patient had insomnia and began having daily shaking episodes and non-epileptic seizures lasting from 30 minutes to 6 hours.As a result, the patient was hospitalized on a neuro unit twice, first for 2 days and then for 4 days.Emergency room (er) treatment was administered on both occasions.For the treatment of insomnia, the patient started taking benadryl, and the immunologist decreased the dose due to ongoing shaking episodes which occurred daily for weeks.After a period of increased benadryl dosage (50 mg/night), the shaking episodes went away.The outpatient neurologist agreed the timing was right for a possible allergic reaction to the euflexxa and had me slowly wean off the benadryl.Action taken with euflexxa was unknown.The outcome of joint pain, allergic reaction to drug, muscle pain, severe headache, extreme fatigue, low back pain, muscle weakness, leg paralysis, insomnia and non-epileptic seizure was unknown.The outcome of daily shaking episodes was recovered.All events in the case were reported as serious.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = mw5149932.Internal # - others = mw5149931 this ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• MDR Report Key: 18669939
• MDR Text Key: 334951819
• Report Number: 0002244564-2024-00009
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Hospitalization