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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Stroke [cerebrovascular accident].This serious spontaneous report was received from a pharmacist in united states.This report concerns a patient of unknown age and gender who experienced a stroke during treatment with euflexxa (sodium hyaluronate) solution for injection 1 %, unknown dose, for an unknown indication from an unknown start date to an unknown stop date.On an unknown date, the patient experienced stroke.The stroke was medically significant.Action taken with euflexxa was dose withdrawn.There was not reported any concomitant medication.This ae occurred in the united states and concerns medical device euflexxa.Please report to your local health authority if required by law.This ae is not reportable in the 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 an eu + efta country and did not result in a corrective action by the manufacturer.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: case number, others = (b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 6058552
• MDR Text Key: 58458217
• Report Number: 3000164186-2016-00017
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other