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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 Cancer (3262)
Event Date 10/02/2018
Event Type  Injury  
Event Description
Mds (myelodysplastic syndrome) [myelodysplastic syndrome]. Case (b)(4) is a serious spontaneous case received from a non health professional via regulatory authority in the united states. This report concerns a female of unknown age who experienced mds (myelodysplastic syndrome) during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, 10 mg, dose unknown, weekly, for osteoarthritis from an unknown start date to an unknown stop date. The patient reported she was diagnosed with mds (myelodysplastic syndrome) in 2018. Patient reported she underwent chemotherapy from 2017 to 2018 and is no longer on chemotherapy since it did not produce the results that were hoped. Medical doctor's office (mdo) is aware and has cleared her for euflexxa injections. Event did not stop after use stopped or dose reduced. Event did not reappear after reintroduction. The event of mds (myelodysplastic syndrome) was medically significant. Action taken to euflexxa was dose reduced. On an unknown date, the outcome of mds (myelodysplastic syndrome) was unknown. The patient's medical history was significant for chemotherapy (from 2017 to 2018). The following concomitant medications were reported: probiotic (from an unknown start date to an unknown stop date), vitamin d3 (from an unknown start date to an unknown stop date). All events in the case were reported as 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: case number, others
=
mw5080429. This ae occurred in 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 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 Key8094781
MDR Text Key128056563
Report Number3000164186-2018-00039
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 other
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
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: 11/21/2018 Patient Sequence Number: 1
Treatment
PROBIOTIC; VITAMIN D3
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