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U.S. Department of Health and Human Services

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

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BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA 1% SODIUM HYALURONATE Back to Search Results
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 Action taken with euflexxa was dose withdrawn.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).
 
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Brand NameEUFLEXXA
Type of Device1% 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 Key6058552
MDR Text Key58458217
Report Number3000164186-2016-00017
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P010029
Number of Events Reported1
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 Received10/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number6301182010
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2016
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 Treatment Data
Date Received: 10/26/2016 Patient Sequence Number: 1
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