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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 Memory Loss/Impairment (1958)
Event Date 08/27/2019
Event Type  Injury  
Event Description
Episodic global amnesia [amnesia]. Case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states. This report concerns a female who experienced episodic global amnesia during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for bilateral primary osteoarthritis from an unknown start date to an unknown stop date. The patient reported that she had episodic global amnesia. The patient was hospitalized on (b)(6) 2019 due to episodic global amnesia. Action taken with euflexxa was unknown. At the time of this report, the outcome of episodic global amnesia was unknown. The following concomitant medications were reported: celebrex, centrum, flexeril, lisinopril, pantoprazole, simvastatin, stimate, zoloft, lorazepam (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
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mw5089502. 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.
 
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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
8443044828
MDR Report Key9202855
MDR Text Key175063377
Report Number3000164186-2019-00045
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 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number6301182010
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
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: 10/17/2019 Patient Sequence Number: 1
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