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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 Device Operates Differently Than Expected (2913)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Joint Swelling (2356); Joint Disorder (2373); Ambulation Difficulties (2544)
Event Date 11/20/2016
Event Type  Injury  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
Haemarthrosis. Could not walk due to amount of swelling [abasia]. Worsening pain [arthralgia]. Swelling of left knee. This serious spontaneous report was initially received from a consumer in united states. Follow up was received from a physician on (b)(6) 2017. Case initially reported as non-serious but upgraded to serious on (b)(6) 2017. This report concerns a (b)(6) male who experienced haemarthrosis, could not walk due to amount of swelling, worsening pain, and swelling of left knee during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, for osteoarthritis from (b)(6) 2016. It was reported that the patient only received two of the three injections. The patient was given his first euflexxa injections in both knees on (b)(6) 2016. After the second set of injections on (b)(6) 2016, he developed swelling in his left knee. He could not walk, due to the amount of swelling, and was taken to the er. He reported that they aspirated blood but was found to not have an infection. The swelling was gone but his pain was worse than before the series began. The physician reported on follow up that 5 days after the second euflexxa injection the patient developed haemarthrosis in his left knee (treatment and outcome are unknown). The physician reported the causality between euflexxa and swelling of the knee as unlikely. Lot number was reported as l16602a. Action taken with euflexxa was dose withdrawn. At the time of this report, the outcome of haemarthrosis was unknown, the outcome of worsening pain was not recovered, the outcome of swelling of left knee was recovered, and the outcome of could not walk due to amount of swelling was unknown. The patient`s medical history was significant for ex-smoke, hypertension, and alcohol use. The patient`s procedure was significant for bilateral x-ray of the knees (from (b)(6) 2016) and aspirated blood. The following concomitant medication was reported: losartan, depomedrol (from (b)(6) 2016 to unknown), and dexamethasone (from 18-oct-2016 to unknown). At the time of reporting the case outcome was unknown. Additional information received on (b)(6) 2017 from patient's physician: case upgraded to serious due to medically significant event. Procedure and medical history updated. Serious event added and narrative updated. Physician reported that patient has transitioned care to another physician and has no additional information. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: (b)(4). The aes occurred in united states and concerns the medical device euflexxa. Please report to your local health authority if required by local law. The aes are 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. (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 Key6352654
MDR Text Key68122796
Report Number3000164186-2017-00002
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
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: 02/23/2017 Patient Sequence Number: 1
Treatment
DEPOMEDROL (METHYLPREDNISOLONE ACETATE); DEXAMETHASONE (DEXAMETHASONE); LOSARTAN (LOSARTAN)
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