MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

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

Patient Problem Injection Site Reaction (4562)

Event Date 09/01/2023

Event Type  Injury  

Event Description

Infection at injection site [injection site infection]; pinkish red spot the size of a half dollar where the injection was on the side of the knee [injection site erythema] pain at that site [injection site pain], knee is killing her where the infection was [injection site pain].Case narrative: this is a serious spontaneous, complaint case received from a consumer in the united states.This report concerns a 74-year-old female who experienced infection at injection site, pinkish red spot the size of a half dollar where the injection was on the side of the knee and pain at that site [injection site pain] during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, and route, weekly for three weeks, for unknown indication from (b)(6) 2023.The patient reported that she had her first euflexxa injection on (b)(6) 2023 and noticed a pinkish red spot the size of a half dollar piece where the injection was on the side of the knee and she experienced pain at that site.The patient did not think anything of it and went back on (b)(6) 2023 for the second injection and the nurse practitioner (np) looked at it and gave her injection in the same exact spot as the last injection.The patient went back for the third injection on (b)(6) 2023 and the np stated it was infected and gave the injection in the front of the knee and prescribed an unspecified antibiotic.The patient took the antibiotic, iced her knee, and put neosporin on it.The np told her the pain was due to her arthritis and the patient asked to speak with the doctor, but the np stated he was busy and that she could go to another doctor if she was not happy.The patient reported that she had a visit with her "heart doctor" who sent her for a venous doppler to rule out a blood clot.The patient underwent the venous doppler and there was no blood clot.The patient reported that her knee was killing her on the side of the knee where the infection was, but the rest of her knee felt great.The patient also mentioned that she had synvisc many years ago and it was wonderful and worked great.The patient declined to provide the prescribing doctor's information as she was afraid of repercussions as she felt like the np did something wrong.The np requested that the patient go for another doppler test, and the patient stated she would go again and reach out to the physician at practice to discuss more.Action taken with euflexxa was not applicable.The patient's med hist/procedure was significant for arthritis (from unknown start date to unknown stop date).No concomitant medication was reported.The event infection at injection site was reported as serious.The events pinkish red spot the size of a half dollar where the injection was on the side of the knee, and pain at that site [injection site pain] were reported as non-serious.At the time of reporting the case outcome was unknown (injection site erythema and injection site infection) not recovered (injection site pain) sender comment: despite of sodium hyaluronate's safety profile, a causal relationship between euflexxa's treatment and the event cannot be ruled out, however, it is considered more likely that the infection is related to the administration procedure or handling of the device and not related to the product per se or the underlying arthritis.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - complaint = (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 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.Case correction 10-oct-2023: in event tab, imdrf code has been added for the serious event.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• MDR Report Key: 17918835
• MDR Text Key: 325451973
• Report Number: 0002244564-2023-00049
• 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: Other
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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): Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female