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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 Pain (1994); Swelling/ Edema (4577)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Could possibly have a blood clot [thrombosis]. Increased pain [pain]. Swelling increased [joint swelling]. Case is a serious complaint, spontaneous case received from a consumer in united states. This report concerns a male patient of unknown age, who "could possibly have a blood clot", increased pain, and swelling increased during treatment with euflexxa (sodium hyaluronate) solution for injection unknown route and concentration, 3 injections, for osteoarthritis from an unknown start date to an unknown stop date. The patient reported that his physician recommended euflexxa injections after knee x-rays were done (unspecified date), which showed his knees to be "bone-on-bone. " after the completion of the euflexxa injections (dates not provided), the patient stated that swelling increased, causing increased pain. The patient reported that his physician had "washed his hands of him" and recommended that he see another physician as the patient "could possibly have a blood clot. " no further information was provided. The "could possibly have a blood clot" was medically significant. Action taken with euflexxa was not applicable. At the time of this report, the outcome of "could possibly have a blood clot" was unknown, the outcome of increased pain was unknown, the outcome of swelling increased was unknown. The patient's med hist/procedure was significant for x-ray (from unknown start date to unknown stop date). No concomitant medication was reported. The event "could possibly have a blood clot" was reported as serious. The events increased pain, swelling increased were reported as non-serious. At the time of reporting the case outcome was unknown. Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the 'possible bloth clot' event, but might most likely be related to the injection administrational procedure. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: unrelated for the blood clot (thrombosis). Other case numbers: internal #: others: (b)(4). Internal #: affiliate: (b)(4). Internal #: complaint: (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 Key12413579
MDR Text Key271465788
Report Number3000164186-2021-00037
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 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
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 Received08/25/2021
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: 09/02/2021 Patient Sequence Number: 1
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