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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 Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Erythema (1840); Pain (1994); Dizziness (2194); Arthralgia (2355); Ambulation Difficulties (2544); Joint Laxity (4526)
Event Date 05/01/2021
Event Type  Injury  
Event Description
Harder to walk on his right knee and it has since gotten worse [gait disturbance]. Knee was going to give out [joint instability]. Toothache like pain in his right knee/ right knee was sore to the touch/he puts weight on his right knee, he has horrific pain [arthralgia]. Redness [erythema]. Stomach ache [abdominal pain upper]. Light headed [dizziness]. Case (b)(4) is a serious complaint, spontaneous case received from a consumer in united states. This report concerns a (b)(6) year-old male who experienced harder to walk on his right knee and it has since gotten worse, knee was going to give out, toothache like pain in his right knee/ right knee was sore to the touch/ he puts weight on his right knee, he has horrific pain, redness, stomach ache and light headed during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown concentration, dose, and route, given weekly for three weeks, for an unknown indication from (b)(6) 2021 to (b)(6) 2021. The patient reported getting three injections of euflexxa in both knees. First dose was on (b)(6) 2021, second on (b)(6) 2021, and third on (b)(6) 2021. After third injection patient experienced redness, and "toothache like" pain in his right knee. He stated that he had stem cell and platelet rich plasma (prp) a couple years ago and things got better for a while. He also reported that he got synvisc in his left knee a while back and it worked well and he wanted to get this in his right knee, but his insurance wouldn't pay. The patient stated prior to euflexxa he had a steroid shot, but that didn't work. After the euflexxa injections it was harder to walk on his right knee and it had gotten worse since. On sunday ((b)(6) 2021) at 9 am, the pain was so severe he felt lightheaded and had a stomachache. When he put weight on his right knee, he had "horrific pain". Yesterday ((b)(6) 2021) he felt like his knee was going to give out, so bought a cane to give support and has applied for short term disability. He said that euflexxa was less painful than other shots, during administration, but afterwards, his right knee was sore to the touch for a whole week after the shot. He stated he was almost pain-free with his left knee after injections, but since then he was experiencing mild pain. No additional information provided. The patient experienced significant disability due walking difficulty action taken with euflexxa was not applicable. At the time of this report, the outcomes of harder to walk on his right knee and it has since gotten worse, knee was going to give out, toothache like pain in his right knee/ right knee was sore to the touch/ he puts weight on his right knee, he has horrific pain, redness, stomach ache and light headed were not recovered. The patient's med hist/procedure was significant for platelet rich plasma (prp) (from unknown start date to unknown stop date) and a-fib (from unknown start date to unknown stop date) and cane user (from unknown start date to unknown stop date) and stem cell (from unknown start date to unknown stop date). The patient's past drug therapy was significant for synvisc (from unknown start date to unknown stop date) and steroid shot (from unknown start date to unknown stop date). The following concomitant medications were reported: metformin (from an unknown start date to an unknown stop date), lisinopril (from an unknown start date to an unknown stop date), verapamil (from an unknown start date to an unknown stop date), metoprolol (from an unknown start date to an unknown stop date). The event harder to walk on his right knee and it has since gotten worse was reported as serious. The events knee was going to give out, toothache like pain in his right knee/ right knee was sore to the touch/ he puts weight on his right knee, he has horrific pain, redness, stomach ache and light headed 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. Other case numbers: internal # - others
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(b)(4). Internal # - affiliate
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(b)(4). Internal # - complaint
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(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 Key12040062
MDR Text Key270051502
Report Number3000164186-2021-00025
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,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number6301182010
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2021
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: 06/22/2021 Patient Sequence Number: 1
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