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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 Material Too Rigid or Stiff (1544)
Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Discomfort (2330)
Event Date 02/13/2019
Event Type  Injury  
Event Description
Knee locked up in the shower and would not bend [joint lock], intractable vomiting [vomiting], stomach sensitive [abdominal discomfort], headache [headache], nausea [nausea]. Case (b)(4) is a serious, spontaneous case received from a consumer via a regulatory authority in united states. This report concerns a patient (no patient identifiers provided) whose knee locked up in the shower and would not bend, experienced intractable vomiting, stomach sensitive, headache and nausea during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for osteoarthritis from (b)(6) 2019. The patient reported that after the first injection of euflexxa on (b)(6) 2019, the patient experienced a headache the first day, intractable vomiting began approximately 22 hours later and the patient was unable to keep food or fluids down for 60 hours. Nausea lasted six days total and stomach was still sensitive. The patient's knee locked up in the shower and would not bend. The patient declined any further injections. The patient reported that they have me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome) and have an overactive immune response and thought it possible that their body saw the euflexxa as in invader of some type. No additional information was provided. Action taken with euflexxa was dose withdrawn. At the time of this report, the outcome of knee locked up in the shower and would not bend was unknown, the outcome of stomach sensitive was not recovered. The outcome of intractable vomiting, nausea and headache were recovered. The patient`s medical history was significant for me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome). The following concomitant medications were reported: synthroid, cytomel, prevacid, vitamin d3, vitamin b12, vitamin b1 and calcium. The event knee locked up in the shower and would not bend was reported as serious. The events intractable vomiting, stomach sensitive, headache, nausea were reported as non-serious. At the time of reporting the case outcome was not recovered. Overall listedness (core label) is unlisted. Reporter causality: related, company causality: related: knee locked up; not related intractable vomiting, stomach sensitive, headache, nausea. Other case numbers: internal # - others
=
mw5084268. This ae occurred in the 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 Key8479532
MDR Text Key140819053
Report Number3000164186-2019-00011
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 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
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 Received03/11/2019
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: 04/03/2019 Patient Sequence Number: 1
Treatment
CALCIUM (CALCIUM); CYTOMEL (LIOTHYRONINE SODIUM); PREVACID (LANSOPRAZOLE); SYNTHROID (LEVOTHYROXINE SODIUM); VITAMIN B1; VITAMIN B12; VITAMIN D3 (COLECALCIFEROL)
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