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

Catalog Number 6301182010

Device Problem Application Program Problem: Medication Error (3198)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Event Description

Consumer experienced a heart attack [myocardial infarction].Consumer completed two out of three injections in the series [incorrect dose administered].Case narrative: this serious spontaneous case received from a physician in the united states.This report concerns a 78-year-old male who completed two out of three injections in the series [incomplete dose administered] and consumer experienced a heart attack during treatment with euflexxa (sodium hyaluronate) solution for injection 1%, two injections, unknown route and frequency, for an unknown indication from an unspecified start date in (b)(6) 2022 to an unknown stop date.The physician reported that a patient began his euflexxa series in (b)(6) 2022 and received two out of three injections and then suffered a heart attack on an unspecified date.The physician stated it had not been a full six months since the start of the series and they didn't know how to move forward with dosing.The consumer experienced a heart attack was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of consumer completed two out of three injections in the series [incomplete dose administered] was unknown.The outcome of consumer experienced a heart attack was unknown.No concomitant medication was reported.The event consumer experienced a heart attack was reported as serious.The event consumer completed two out of three injections in the series [incomplete dose administered] was reported as non-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, route of administration, as well as the details relating to the heart attack preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused a heart attack to this elderly patient.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: 16551694
• MDR Text Key: 311381373
• Report Number: 0002244564-2022-00038
• 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: Physician
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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
• Is the Reporter a Health Professional?: Yes
• 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: 78 YR
• Patient Sex: Male