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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 Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problems Arthritis (1723); Therapeutic Response, Decreased (2271); Injury (2348); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544); Osteomyelitis (4533); Swelling/ Edema (4577); Peripheral Edema (4578)
Event Date 01/01/2020
Event Type  Injury  
Event Description
Bone infection [osteomyelitis]. Condition worsened [condition aggravated]. Bone marrow edema [bone marrow oedema]. Right toe swelled up [peripheral swelling]. Meniscus failing [meniscus injury]. Couldn't put any weight on her leg (left) [weight bearing difficulty]. Concerned there may be some type of contaminant, maybe fungus [occupational exposure to air contaminants]. Knee swelled up [joint swelling]. Knee was more painful [arthralgia]. Right knee was mildly inflamed [arthritis]. Euflexxa injected in patient's right toe [product administered at inappropriate site]. Patient did not get normal response [therapeutic response decreased]. Euflexxa injected for toe because of arthritis [drug use for unapproved indication]. [product use in unapproved indication]. Off label use [off label use]. Case (b)(4) is a serious complaint, spontaneous case received from a physician in united states. This report concerns a (b)(6)-year-old female who experienced bone infection, condition worsened, bone marrow edema, right toe swelled up, meniscus failing, could not put any weight on her leg (left), concerned there may be some type of contaminant, maybe fungus, knee swelled up, knee was more painful, right knee was mildly inflamed, euflexxa injected in patient's right toe, patient did not get normal response, euflexxa injected for toe because of arthritis [drug use for unapproved indication] and off label use during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration weekly for 3 weeks, for product used for unknown indication from (b)(6) 2020. The physician reported that he had administered euflexxa to a patient (once a year for the past three to four years with him) and experienced a reaction after her third injection on (b)(6) 2020. The doctor reported the patient received injections in both knees, although four days after the last injection, her left knee swelled up and was more painful, described as she did not get normal response. Her right knee was only mildly inflamed, but nothing like the left knee. Doctor reported that he also had a small amount left in his euflexxa vial from right knee, so he injected patient's right toe, because of arthritis. The patient's right toe swelled up as well. Doctor did run many cultures, and all were negative, he drained her left knee multiple times. Magnetic resonance imaging (mri) was done and showed bone infection. The reactions fluctuated, were bad, and then he used cortisone, and it was a little better, but cortisone really did not work, and then became bad again. He stated her condition worsened and she couldn't put any weight on her leg (left) and it was constantly inflamed. The patient went to surgeon and the surgeon stated it was due to her meniscus failing (from a previous allograft meniscus transplant) and she had knee surgery six weeks after euflexxa. The doctor reported that he did a repeat mri and it showed bone marrow edema (left knee). The surgeon stated that knee and right foot (toe) cultures are negative and synovial biopsy of left knee was also negative for infections. Doctor did report that patient had pseudosepsis reaction from another unknown knee medication in the past, although with another doctor. No further information was provided. The bone infection was medically significant. Action taken with euflexxa was not applicable. At the time of this report, the outcome of bone marrow edema was not recovered, the outcome of bone infection was not recovered, the outcome of condition worsened was not recovered, the outcome of right toe swelled up was not recovered, the outcome of meniscus failing was not recovered, the outcome of could not put any weight on her leg (left) was not recovered, the outcome of concerned there may be some type of contaminant, maybe fungus was unknown, the outcome of right knee was mildly inflamed was not recovered, the outcome of patient did not get normal response was not recovered, the outcome of knee swelled up was not recovered, the outcome of knee was more painful was not recovered. In (b)(6) 2020, the outcome of euflexxa injected in patient's right toe was recovered, the outcome of euflexxa injected for toe because of arthritis [drug use for unapproved indication] was recovered, the outcome of off label use was recovered. The patient's med hist/procedure was significant for drained knee (from 2020 to unknown stop date) and allograft meniscus transplant (from unknown start date to unknown stop date) and knee surgery (from 2020 to 2020) and pseudosepsis reaction (from unknown start date to unknown stop date) and arthritis (from unknown start date to unknown stop date). No concomitant medication was reported. The event bone infection was reported as serious. The events condition worsened, bone marrow edema, right toe swelled up, meniscus failing, could not put any weight on her leg (left), concerned there may be some type of contaminant, maybe fungus, knee swelled up, knee was more painful, right knee was mildly inflamed, euflexxa injected in patient's right toe, patient did not get normal response, euflexxa injected for toe because of arthritis [drug use for unapproved indication], off label use were reported as non-serious. At the time of reporting the case outcome was unknown. Sender comments: despite the temporal relationship between some of the reported events and euflexxa, events of 'bone marrow edema', 'bone infection', 'condition worsened', 'knee swelled', 'knee was more painful', 'could not put any weight on her leg (left)', 'patient did not get normal response' and 'right knee was mildly inflamed' are to be related to a pseudosepsis reaction from another unknown knee medication in the past as stated by the reporting physician. These events are also compatible with the already existing meniscus injury. Furthermore, cultures and synovial biopsy of left knee were negative for infections. Ferring gpv is waiting for the complaint's investigation's results. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: (b)(4). 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 Key11388238
MDR Text Key244382116
Report Number3000164186-2021-00006
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,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2021
Device Catalogue Number6301182010
Device Lot NumberR13626A
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 Received03/16/2021
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: 02/26/2021 Patient Sequence Number: 1
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