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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Nausea (1970); Concussion (2192); Urinary Frequency (2275); Malaise (2359); Loss of consciousness (2418)
Event Date 05/17/2017
Event Type  Injury  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
Passed out [loss of consciousness], had a concussion [concussion], began to urinate more often than usual (every 20 minutes) [pollakiuria], vomiting [vomiting], nausea [nausea], diarrhea [diarrhoea], feeling sick [malaise]. This serious spontaneous report was received from a consumer in united states. This report concerns a (b)(6) female who passed out, experienced a concussion, began to urinate more often than usual (every 20 minutes), vomiting, nausea, diarrhea, and feeling sick during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unk, weekly, for osteoarthritis from (b)(6) 2017 to an unknown stop date. The patient stated that she received one euflexxa shot in both knees on (b)(6) 2017. The morning after the shot ((b)(6) 2017), she began to urinate more often than usual (every 20 minutes) and later, in the middle of the night, on (b)(6) 2017, she began to experience nausea, vomiting, diarrhea, and feeling sick. When the patient tried to walk to the couch, she passed out and experienced a concussion. She went to the emergency room (er) on (b)(6) 2017. The experienced a concussion was medically significant. The passed out was medically significant. Action taken with euflexxa was unknown. On an unknown date, the outcome of passed out and experienced a concussion was unknown. In 2017, the outcome of began to urinate more often than usual (every 20 minutes), vomiting, nausea, diarrhea, and feeling sick was recovered. The following concomitant medications were reported: meloxicam (from an unknown start date to an unknown stop date), simvastatin (from an unknown start date to an unknown stop date), gabapentin (from an unknown start date to an unknown stop date). At the time of reporting, the case outcome was unknown. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: case number, (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
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 Key6677750
MDR Text Key78720786
Report Number3000164186-2017-00014
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 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2017
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: 06/29/2017 Patient Sequence Number: 1
Treatment
GABAPENTIN (GABAPENTIN); MELOXICAM (MELOXICAM); SIMVASTATIN (SIMVASTATIN)
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