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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Myocardial Infarction (1969)
Event Date 11/06/2020
Event Type  Death  
Event Description
Heart attack [myocardial infarction]. Case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in the united states. This report concerns a patient (no patient identifiers reported) who experienced a heart attack during treatment with euflexxa (sodium hyaluronate) solution for injection intra-articular, unknown concentration, dose or frequency, used for unknown indication from an unknown start date to an unknown stop date. The husband of the patient reported that on (b)(6) 2020, the patient died of a heart attack. Action taken with euflexxa was not applicable. At the time of reporting, the outcome of heart attack was fatal. No concomitant medication was reported. All events in the case were reported as serious. At the time of reporting the case outcome was fatal. Sender comments: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, administration dates, as well as the details relating to the death of the patient preventing a proper medical assessment. Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's death. Company causality unrelated. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: unrelated. Other case numbers: internal # - others
=
mw5103178. 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.
 
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Brand NameEUFLEXXA
Type of Device1% SODIUM HYALURONATE
Manufacturer (Section D)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
be'er tuvia industrial zone
pob 571
kiryat malachi, 83104
IS 83104
Manufacturer (Section G)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
be'er tuvia industrial zone
pob 571
kiryat malachi, 83104
IS 83104
Manufacturer Contact
100 interpace parkway
parsippany, NJ 07054
9737961600
MDR Report Key12413249
MDR Text Key269517892
Report Number3000164186-2021-00036
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/02/2021 Patient Sequence Number: 1
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