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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 Dyspnea (1816); Pain (1994); Sore Throat (2396)
Event Type  Injury  
Event Description
Trouble breathing [dyspnoea]. Sore throat [oropharyngeal pain]. Case (b)(4) is a serious spontaneous case received from a health professional via the fda in united states. This report concerns a patient (no patient identifiers reported), who experienced trouble breathing and sore throat during treatment with intra-articular euflexxa (sodium hyaluronate) 10 mg solution for injection at an unknown dose, for osteoarthritis from an unknown start date to an unknown stop date. The patient went to the hospital emergency room on unspecified dates in (b)(6) 2019 and the present for trouble breathing. The patient reported having a sore throat for the past few months and had been through two rounds of amoxicillin and a round of prednisone. No additional information was provided. The patient was hospitalised on an unknown date due to trouble breathing. Action taken with euflexxa was unknown. At the time of this report, the outcome of trouble breathing and sore throat was unknown. The following concomitant medication was reported: haloperidol (from an unknown start date to an unknown stop date). The event trouble breathing was reported as serious. The event sore throat was 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: internal # - others
=
mw5089089. 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 Key9148287
MDR Text Key167631337
Report Number3000164186-2019-00041
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 Other Health Care Professional
Type of Report Initial
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
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 Received09/03/2019
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: 10/02/2019 Patient Sequence Number: 1
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