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 Ischemia Stroke (4418)

Event Type  Injury  

Event Description

Patient suffered a mini stroke [transient ischaemic attack].Case narrative: case (b)(4) is a serious complaint spontaneous case received from a non healthcare professional via regulatory authority in united states.This report concerns a patient (no identifiers reported) who suffered from a mini stroke during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unknown dose and frequency for an unknown indication from an unknown start date and ongoing.The non healthcare professional reported the patient suffered from a mini stroke.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of patient suffered from a mini stroke was unknown.The following concomitant medications were reported: synthroid (from an unknown start date to an unknown stop date), ibuprofen (from an unknown start date to an unknown stop date).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: not related.Other case numbers: internal # - others = mw5095600.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 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.Ferring's sender comment: despite the limited information in the report on the patient's medical history, euflexxa treatment details (therapy dates, and indication), and event details (clinical course and outcome), association between euflexxa and mini stroke is unrelated due to lack of biological plausibility.

• 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: 16551691
• MDR Text Key: 311479680
• Report Number: 0002244564-2020-00012
• 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: IBUPROFEN (IBUPROFEN).; SYNTHROID (LEVOTHYROXINE SODIUM).
• Patient Outcome(s): Required Intervention; Other