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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 Respiratory Distress (2045); Swelling (2091)
Event Date 05/17/2016
Event Type  Injury  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
Facial swelling [swelling face]; broncho distress [respiratory distress]. This serious spontaneous report was received from a medical assistant in united states. This report concerns a (b)(6) female who experienced facial swelling and broncho distress during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, 1 injection, weekly for 3 weeks, for osteoarthritis from (b)(6) 2016. It was reported that the patient received euflexxa for osteoarthritis of the right knee starting on (b)(6) 2016. The patient received her third dose on (b)(6) 2016 and 5 days post injection, the patient experienced facial swelling and bronco distress. The patient was hospitalized (date, duration, and treatment not provided). Action taken with euflexxa was dose not changed. On an unknown date, the outcome of facial swelling was recovered, the outcome of broncho distress was recovered. The following concomitant medication was reported: diltiazem, duloxetine, sotalol, clonazepam, montelukast, gabapentin. At the time of reporting the case outcome was recovered. Additional information on 21-feb-2017: corrected source document. Route corrected to intra-articular. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. (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
kiryat malachi, 83104
IS 83104
Manufacturer (Section G)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
be'er tuvia industrial zone
kiryat malachi, 83104
IS 83104
Manufacturer Contact
100 interpace parkway
parsippany, NJ 07054
9737961600
MDR Report Key6411488
MDR Text Key70171558
Report Number3000164186-2017-00004
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 Medical Assistant
Type of Report Initial
Report Date 02/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
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 Received02/21/2017
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: 03/16/2017 Patient Sequence Number: 1
Treatment
CLONAZEPAM (CLONAZEPAM); DILTIAZEM (DILTIAZEM); DULOXETINE (DULOXETINE); GABAPENTIN (GABAPENTIN); MONTELUKAST (MONTELUKAST); SOTALOL (SOTALOL)
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