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

Catalog Number 6301182010

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Peripheral Nervous Injury (4414)

Event Type  Injury  

Event Description

Pulmonary embolism [pulmonary embolism].Drop foot in his right foot [peroneal nerve palsy].Left knee became irritated and increased [limb discomfort].Pain in his left knee [arthralgia].Case narrative: (b)(4) is a serious complaint spontaneous case received from a consumer in united states.This report concerns a 56-year-old male who experienced pulmonary embolism, drop foot in his right foot, left knee became irritated and increased and pain in his left knee during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and weekly for 3 weeks, during the last three weeks of december for osteoarthritis from (b)(6) 2020 to (b)(6) 2020.The patient stated that he had great relief with the first series of euflexxa injections in his left knee in (b)(6) of 2020.In (b)(6) 2020, he experienced drop foot in his right foot, and had to undergo surgery on the nerve in his right leg.He started doing physiotherapy for the drop foot and his left knee became irritated.He received another series of euflexxa during the last three weeks of (b)(6) 2020, and in (b)(6) 2021, he experienced a pulmonary embolism.He again had increased irritation and pain in his left knee with the physiotherapy for his drop foot and stated he was not able to take any nonsteroidal anti-inflammatory drugs (nsaids) because of the pulmonary embolism.The patient was taking xarelto for pulmonary embolism.No further information reported.The pulmonary embolism was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of pulmonary embolism was unknown, the outcome of drop foot in his right foot was unknown, the outcome of left knee became irritated and increased was unknown, the outcome of pain in his left knee was unknown.The patient's med hist/procedure was significant for surgery on the nerve in his right leg (from (b)(6) 2020 to unknown stop date) and physiotherapy (from unknown start date to unknown stop date).The following concomitant medications were reported: tylenol (from an unknown start date to an unknown stop date), prozac (from an unknown start date to an unknown stop date), fenofibric acid (from an unknown start date to an unknown stop date), clarinex [desloratadine] (from an unknown start date to an unknown stop date).The event pulmonary embolism was reported as serious.The events drop foot in his right foot, left knee became irritated and increased, pain in his left knee were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: despite of sodium hyaluronate's safety profile it is considered highly unlikely that the pulmonary embolism is related to euflexxa, hence considered as not related to euflexxa.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: 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 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
• 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: 16551687
• MDR Text Key: 311479464
• Report Number: 0002244564-2021-00020
• 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: 03/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: CLARINEX [DESLORATADINE] (DESLORATADINE).; FENOFIBRIC ACID (FENOFIBRIC ACID).; PROZAC (FLUOXETINE HYDROCHLORIDE).; TYLENOL (PARACETAMOL).
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male
• Patient Weight: 145 KG