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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 Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problems Arthritis (1723); Pain (1994)
Event Type  Injury  
Event Description
Seronegative spondyloarthropathy [seronegative arthritis]. Seronegative spondyloarthropathy [spondyloarthropathy]. Knee pain [device use for unapproved indication] [device use issue]. Off label use [off label use]. Case (b)(4) is a serious spontaneous case received from a physician in united states. This report concerns a female patient (no identifiers reported) who experienced seronegative spondyloarthropathy, knee pain [device use for unapproved indication] and off label use during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for knee pain from an unknown start date to an unknown stop date. The physician reported the patient received the series of three injections for knee pain, and then in ensuing weeks developed what seemed like a seronegative spondyloarthropathy, and wanted to know if this was an occurrence that had happened elsewhere, and if there was any way it can be effectively treated other than oral prednisone. The seronegative spondyloarthropathy was medically significant. Action taken with euflexxa was not applicable. At the time of this report, the outcome of seronegative spondyloarthropathy was unknown, the outcome of knee pain [device use for unapproved indication] was recovered, the outcome of off label use was recovered. No concomitant medication was reported. The event seronegative spondyloarthropathy was reported as serious. The events knee pain [device use for unapproved indication], off label use were reported as non-serious. At the time of reporting the case outcome was unknown. Sender comment: based on the known safety profile, when used according to label (this case olu), company causality is considered not related to euflexxa for the 'seronegative spondyloarthropathy' event as there is no clinical evidence. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: internal # - others
=
(b)(4).
 
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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 Key11706644
MDR Text Key247157524
Report Number3000164186-2021-00014
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 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
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 Received03/29/2021
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: 04/22/2021 Patient Sequence Number: 1
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