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 Thrombosis/Thrombus (4440)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Blood clot in the leg [thrombosis].Case narrative: (b)(4) is a serious spontaneous case received from a nurse in united states.This report concerns a male of an unknown age who experienced blood clot in the leg during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and once/single for an unknown indication from (b)(6) 2021 to an unknown stop date.The nurse reported that they have a patient who received his first injection on (b)(6) 2021.Afterwards, the patient acquired a blood clot in the same leg as the injection and ended up having to cancel his following appointments.His primary care doctor did not want him to continue euflexxa, but had now since, stated he can resume the treatment.No further information reported.The blood clot in the leg was medically significant.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of blood clot in the leg was unknown.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: 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: 16551686
• MDR Text Key: 311380381
• Report Number: 0002244564-2021-00029
• 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: Nurse
• 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): Other; Required Intervention
• Patient Sex: Male