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

Catalog Number 6301182010

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Event Description

Heart attack [myocardial infarction].Case narrative: case (b)(4) is a serious spontaneous case received from a health professional via a sales representative in united states.This report concerns a male patient of unknown age, who experienced a heart attack during treatment with euflexxa (sodium hyaluronate) solution for injection unknown route and concentration 1 dose, for unknown indication from (b)(6) 2021 to an unknown stop date.The medical assistant reported that the patient had his first injection on (b)(6) 2021 and then had a heart attack (unspecified time frame between first injection and heart attack).The patient did not receive the second or third injection due to the need for extensive care.The reporter stated that the patient will be continuing with injections.The heart attack was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of heart attack was recovered.Concomitant medication and medical history were not reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, event onset date etc.Preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's heart attack.Company causality unrelated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = (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: 16551695
• MDR Text Key: 311380036
• Report Number: 0002244564-2021-00041
• 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 Health Care 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
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male