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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 Problem Bacterial Infection (1735)
Event Type  Injury  
Event Description
Culture of patient's right knee which revealed e. Coli [escherichia infection]. Case (b)(4) is a serious spontaneous case received from a health professional in united states. This report concerns a female whose right knee culture revealed e. Coli, after treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration unknown dose, for osteoarthritis from an unknown start date to an unknown stop date. According to the physician's assistant (pa) the patient experienced pain and swelling of her right knee about five days after receiving her first euflexxa injection. The pa did a culture of patient's right knee which revealed e. Coli. As treatment, a wash out of her right knee was done and patient was on iv antibiotics for a few days. The patient was currently on an unspecified oral antibiotic. The office will hold onto the remaining two syringes in case its needed. No further information was provided. The culture revealed e. Coli was medically significant. Action taken with euflexxa was unknown. At the time of the report, the outcome of culture of patient's right knee which revealed e. Coli was unknown. No concomitant medication was reported. 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: (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 Key8670874
MDR Text Key147084474
Report Number3000164186-2019-00017
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 Physician Assistant
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/02/2019
Device Catalogue Number6301182010
Device Lot NumberN16870A
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 Received05/16/2019
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: 06/05/2019 Patient Sequence Number: 1
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