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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 Fall (1848); Malaise (2359); Loss of consciousness (2418)
Event Date 10/26/2018
Event Type  Injury  
Event Description
Lost consciousness [loss of consciousness]. Fell [fall]. Got sick [malaise]. Case (b)(4) is a serious spontaneous case received from a pharmacist via a regulatory authority in the united states. This report concerns a female of unknown age who lost consciousness, fell, and got sick during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, dosing regimen unknown, for osteoarthritis (beginning on 2018 and ongoing). The reporter stated that the patient received the euflexxa injection on wednesday ((b)(6) 2018) at her doctor's office and following "got sick" on friday ((b)(6) 2018). Furthermore, the patient lost consciousness and fell. Subsequently, the patient went to the emergency room (er) where they a ct (computerised tomogram) scan and mri (nuclear magnetic resonance imaging) were performed; however, in the er they were unable to identify a cause. The results of ct scan and mri were not specified. The patient's next euflexxa injection was scheduled for next wednesday ((b)(6) 2018). Action taken with euflexxa was reported as dose not changed. The following concomitant medication was reported: losartan (from unknown start to unknown stop date). The event lost consciousness was reported as serious. The events fell, got sick were reported as non-serious. At the time of reporting the case outcome was unknown. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: not related. Other case numbers: e2b report duplicate
=
mw5081160. These aes occurred in united states and concerns the medical device euflexxa. Please report to your local health authority if required by local law. These aes are not reportable in eu because they 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 Key8143284
MDR Text Key129657326
Report Number3000164186-2018-00040
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 Pharmacist
Type of Report Initial
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
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: 12/07/2018 Patient Sequence Number: 1
Treatment
LOSARTAN
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