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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 Dyspnea (1816); Respiratory Distress (2045); Arthralgia (2355); Joint Swelling (2356); Palpitations (2467)
Event Date 09/01/2018
Event Type  Injury  
Event Description
Increased heart rate [heart rate increased]. Shortness of breath [dyspnoea]. Pain in knee [arthralgia]. Swelling of the knee [joint swelling]. Case (b)(4) is a serious spontaneous case received from a nurse via a company representative in the united states. This report concerns a (b)(6) male who experienced increased heart rate, shortness of breath, pain in knee and swelling of the knee during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 2 ml, 2 ml, weekly, for osteoarthritis from (b)(6) 2018 to (b)(6) 2018. The reporter stated that the patient had his first euflexxa injection on (b)(6) 2018 and within 24 hours, he went to the emergency room (er) due to pain and swelling of the knee. The patient also had an increased heart rate and shortness of breath. He returned to his prescribing physician's office on (b)(6) 2018 although stated that he did not want the second euflexxa injection due to pain, swelling, increased heart rate, and shortness of breath. The patient was still being treated by his primary care physician for shortness of breath and higher heart rate and was taking benadryl and an inhaler. The reporter stated that the prescribing physician did not believe the shortness of breath and higher heart rate were due to euflexxa, although the patient's primary care physician called inquiring about events and euflexxa. The lot number was reported as n16424a with an expiration date of 21-aug-2019. The shortness of breath was medically significant. The increased heart rate was medically significant. Action taken to euflexxa was dose withdrawn. At the time of this report, the outcome of increased heart rate was not recovered, the outcome of shortness of breath was not recovered, the outcome of pain in knee was not recovered, and the outcome of swelling of the knee was not recovered. Concomitant medication and medical history were reported as unknown. The events increased heart rate, shortness of breath were reported as serious. The events pain in knee, swelling of the knee were reported as non-serious. At the time of reporting the case outcome was not recovered. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: case number, others
=
(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 manufacture. 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 Key7968685
MDR Text Key123807248
Report Number3000164186-2018-00027
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
Type of Report Initial
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/21/2019
Device Catalogue Number6301182010
Device Lot NumberN16424A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
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: 10/16/2018 Patient Sequence Number: 1
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