MAUDE Adverse Event Report: EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

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

Patient Problems Pain (1994); Arthralgia (2355); Pharyngitis (2367); Ambulation Difficulties (2544); Cough (4457); Swelling/ Edema (4577)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Cannot walk [gait inability], nose was running [rhinorrhoea], achy all over [pain], cannot put any pressure on her knee [weight bearing difficulty], really warm to the touch [medical device site joint warmth], could not stop coughing [cough], really bad cold [nasopharyngitis], back hurts [back pain], knee is swollen [joint swelling], next day her knee hurt really bad where the injection went in, having lot of pain in knee [arthralgia], looks like the gel went under neither her knee cap [joint effusion], scheduled second injection for monday ((b)(6) 2021) [inappropriate schedule of product administration].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer in united states.This report concerns a 55-year-old female who experienced cannot walk, really bad cold, could not stop coughing, nose was running, achy all over, cannot put any pressure on her knee, really warm to the touch, back hurts, knee was swollen, next day her knee hurt really bad where the injection went in, having lot of pain in knee, looks like the gel went under neither her knee cap and scheduled second injection for monday ((b)(6) 2021) during treatment with unknown euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for an unknown indication from (b)(6) 2021 and ongoing.The patient reported getting her first injection on monday ((b)(6) 2021) at 4 o'clock and stated that the next day her knee hurt really bad where the injection went in.Her knee is swollen, her back hurts and she came down with a really bad cold.She said she feels like she was sick, and her nose was running.The patient couldn't stop coughing and stated she had to take benadryl.She was having a lot of pain in her right knee, and it has not gotten any better.She also reported that she was achy all over and was questioning if she was having an allergic reaction to euflexxa.She was still having a lot of knee pain to the point where she cannot walk or put any pressure on her knee.It was still a little swollen and it was originally really warm to the touch, and it still gets warm at night.The patient stated that it looks like the gel went under neither her knee cap.She was supposed to get the second injection on (b)(6) 2021 but didn't because of the pain.The doctor had explained to her that it was her decision whether she would like to move forward with the next injection or not.She had rescheduled the second injection for monday (28-jun-2021).Upon asking if she has already called and reported this, she stated that she called a solutions center.No further information provided.The cannot walk was medically significant.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of cannot walk was not recovered, the outcome of really bad cold was not recovered, the outcome of could not stop coughing was not recovered, the outcome of nose was running was not recovered, the outcome of achy all over was not recovered, the outcome of cannot put any pressure on her knee was not recovered, the outcome of really warm to the touch was not recovered, the outcome of back hurts was not recovered, the outcome of knee is swollen was not recovered, the outcome of next day her knee hurt really bad where the injection went in, having lot of pain in knee was not recovered, the outcome of looks like the gel went under neither her knee cap was not recovered, the outcome of scheduled second injection for monday ((b)(6) 2021) was not recovered.No concomitant medication was reported.The event cannot walk was reported as serious.The events really bad cold, could not stop coughing, nose was running, achy all over, cannot put any pressure on her knee, really warm to the touch, back hurts, knee is swollen, next day her knee hurt really bad where the injection went in, having lot of pain in knee, looks like the gel went under neither her knee cap, scheduled second injection for monday ((b)(6) 2021) were reported as non-serious.At the time of reporting the case outcome was not recovered.Sender comments: important information has not been reported for this case including the patient's medical history, laboratory findings product indication, concomitant medication, dosing regimen etc.Preventing a proper medical assessment.Furthermore, due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the events of: rhinorrhoea, pain (all over), cough and nasopharyngitis.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related for events: 'noise was running', 'achy all over', 'could not stop coughing and 'really bad cold.Other case numbers: (b)(4).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 medical device directive/ because it did not occur in a eu + efta country 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: 16439027
• MDR Text Key: 310243743
• Report Number: 0002244564-2021-00027
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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): Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 59 KG