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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 Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Patient Problems Arthritis (1723); Pain (1994); Arthralgia (2355); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
Not able to move for about four weeks [immobile]. Contractions and muscle jumping in the hamstring and the back of the treated knee [muscle contractions involuntary]. There was some cartilage in there and i think the medication went in and ripped it up [also described as there was damage done] [cartilage injury]. Pain [clarified by contractions and muscle jumping in the hamstring and the back of the treated knee] [arthralgia]. Knee swelling [joint swelling]. Osteoarthritis did not improve following the euflexxa series [device ineffective]. This serious complaint, spontaneous report was received from a consumer in united states. Case initially reported as non-serious but upgraded to serious on 18-jan-2017. This report concerns a (b)(6) female who experienced not able to move for four weeks, contractions and muscle jumping in the hamstring and the back of the treated knee, there was some cartilage in there and i think the medication went in and ripped it up, pain, knee swelling, and osteoarthritis did not improve following the euflexxa series during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, weekly, for osteoarthritis from (b)(6) 2016. The patient reported that she was administered euflexxa for osteoarthritis of the right knee. The patient reported that she received her first euflexxa injection on (b)(6) 2016. She reported being on the couch all day and having an awful reaction to the product. It was clarified that the reaction was pain and described the pain as contractions and muscle jumping in the hamstring and the back of the treated knee. A second dose was administered on (b)(6) 2016, with a similar but less severe reaction. The patient received her third dose on (b)(6) 2016. The patient's osteoarthritis did not improve following the euflexxa series, and on (b)(6) 2016, under the care of a different physician, the patient underwent knee surgery. The patient feels that treatment with euflexxa hastened the need for knee surgery. Upon follow up the patient further reported that after the euflexxa injection she was not able to move for four weeks. She reported she had pain before receiving the injections, but was at least able to hobble around, as opposed to after the medication. The patient clarified that the knee surgery was a total knee replacement. She claimed to have swelling in the knee that was present after euflexxa and before her surgery. The patient also stated there was some cartilage in there (presumed to be discussing the knee) and she believes the medication went in and ripped it up. Action taken with euflexxa was dose not changed. On an unknown date, the outcome of not able to move for about four weeks was recovered. The outcome of pain was unknown. The outcome of "there was some cartilage in there" and "i think the medication went in and ripped it up [also described as there was damage done]" was not recovered. The outcome of "knee swelling" was not recovered, the outcome of "contractions and muscle jumping in the hamstring and the back of the treated knee " was not recovered, the outcome of "osteoarthritis did not improve following the euflexxa series" was unknown. The patient`s medical history was significant for thyroid condition and glaucoma. The patient`s past drug therapy was significant for corticosteroid injections. The patient`s procedure was significant for complete knee replacement. Concomitant medication use was reported as unknown thyroid medication. At the time of reporting the case outcome was not recovered. Additional information was received on 18-jan-2017 from the initial reporter: case upgraded to serious. Additional events, outcomes, and seriousness criteria updated. Narrative updated. Overall listedness (core label) is unlisted. Reporter causality: related company causality: related other case numbers: (b)(4). This ae occurred in the us 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. (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 Key6310686
MDR Text Key66817678
Report Number3000164186-2016-00040
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
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: 02/08/2017 Patient Sequence Number: 1
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