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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 Pulmonary Edema (2020)
Event Date 08/25/2021
Event Type  Injury  
Event Description
Fluid in lungs [pulmonary oedema]. Case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in united states. This report concerns a patient (no patient identifiers provided) who experienced fluid in lungs during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg, unk, for product used for unknown indication from an unknown start date to an unknown stop date. The patient's wife reported that the patient was admitted to the hospital for five days for fluid in the lungs and was on amoxicillin for treatment. Event date was reported as (b)(6) 2021. The patient "had not yet filled medication" (not otherwise specified). The patient was hospitalised on an unknown date due to fluid in lungs. Action taken with euflexxa was unknown. At the time of this report, the outcome of fluid in the lungs was unknown. No concomitant medication or medical history were reported. All events in the case were reported as serious. At the time of reporting the case outcome was unknown. Sender comments: important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication preventing a proper medical assessment. Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's fluid in the lungs. Company causality not related. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: not related. Other case numbers: internal # - others
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mw5103726. 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 Key12608967
MDR Text Key276104936
Report Number3000164186-2021-00042
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
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
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: 10/11/2021 Patient Sequence Number: 1
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