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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 Insufficient Information (3190)
Patient Problems Dysphasia (2195); Loss of consciousness (2418); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Speech Disorder (4415); Joint Laxity (4526)
Event Date 09/16/2021
Event Type  Injury  
Event Description
Became unconscious [loss of consciousness], horrible bowel movement [bowel movement irregularity], knees buckled [joint instability], shaky [tremor], very disoriented [disorientation], could not verbalize my thoughts [aphasia], er thought i was having a stroke [cerebrovascular accident]. Case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in united states. This report concerns a female of unknown age who became unconscious, horrible bowel movement, knees buckled, shaky, very disoriented and could not verbalize my thoughts/the emergency room thought she was having a stroke, during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration, used for unknown indication from an unknown start date to an unknown stop date. The patient reported that on (b)(6) 2021, about three hours after receiving euflexxa injection into the right knee, she had a "horrible bowel movement", knees buckled, and she had to sit down as she was very shaky. The patient's friend suggested taking her blood pressure, but she was too shaky to do so. The friend took the patient to the emergency room where she stayed overnight. The patient was very disoriented, could not verbalize her thoughts and stated the emergency room thought she was having a stroke. The patient became unconscious. The patient had called the orthopedic office and told them about how she was feeling after the injection. They had told her to call the next day ((b)(6) 2021) if she did not feel better. Since she ended up in the emergency room, she was not able to call them. The emergency doctor called the patient's doctor. No further information was reported. The patient was hospitalized on (b)(6) 2021 due to became unconscious. The patient was hospitalized on (b)(6) 2021 due to horrible bowel movement. The patient was hospitalized on (b)(6) 2021 due to knees buckled. The patient was hospitalized on (b)(6) 2021 due to shaky. The patient was hospitalized on (b)(6) 2021 due to very disoriented. The patient was hospitalized on (b)(6) 2021 due to could not verbalize my thoughts. The patient was hospitalized on (b)(6) 2021 due to emergency room thought she was having a stroke. Action taken with euflexxa was unknown. At the time of the report, the outcome of became unconscious was unknown, the outcome of horrible bowel movement was unknown, the outcome of knees buckled was unknown, the outcome of shaky was unknown, the outcome of very disoriented was unknown, the outcome of could not verbalize my thoughts was unknown, the outcome of emergency room thought she was having a stroke was unknown. The following concomitant medications were reported: zinc (from an unknown start date to an unknown stop date), probiotics nos (from an unknown start date to an unknown stop date), ester-c [ascorbic acid] (from an unknown start date to an unknown stop date), vitamin k 2 (from an unknown start date to an unknown stop date), fish oil (from an unknown start date to an unknown stop date). All events in the case were reported as serious. At the time of reporting the case outcome was unknown. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: not related. Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, product indication, preventing a proper medical assessment. Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the reported events became unconscious, horrible bowel movement, knees buckled, shaky, very disoriented and could not verbalize my thoughts. Company causality unrelated. Other case numbers: internal # - others
=
mw5104173. 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 Key12616413
MDR Text Key276105615
Report Number3000164186-2021-00043
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 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
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: 10/12/2021 Patient Sequence Number: 1
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