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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Headache (1880); Arthralgia (2355); Inadequate Pain Relief (2388)
Event Date 03/01/2020
Event Type  Injury  
Event Description
Rheumatoid arthritis [rheumatoid arthritis]. Aching again [knee] [arthralgia]. Swelling in her knee went down [joint swelling]. Headache [headache]. Euflexxa was not effective now [therapeutic product effect decreased]. In the past she has had all three injections at once [product use issue]. Case (b)(4) is a serious complaint spontaneous case received from a consumer in united states. This report concerns a female of an unknown age who experienced rheumatoid arthritis, euflexxa was not effective now, headache, in the past she has had all three injections at once, swelling in her knee went down and aching again [knee] during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for unknown indication from (b)(6) 2020 to an unknown stop date. The female patient who had been using euflexxa for 12 years reported that it was not as effective now and she was not getting relief. She reported that after her first injection of last series on (b)(6) 2020, she had a headache that lasted for four days. She described it as not a typical headache, but that her head ached at the top, and her eyes and ears ached. She also reported that her rheumatoid arthritis acted up. She had second injection on (b)(6) 2020 and had a headache again for four days. She stated in the past she had all three injections at once as well as spreading them out weekly. She spoke to physician assistant (pa) at new office and asked if she could "spread out" the three injections. The pa stated that there was no preference and she could spread out if requested. The patient reported that the swelling in her knee went down but in the past two to three days it is aching again. The rheumatoid arthritis was medically significant. Action taken with euflexxa was not applicable. At the time of this report, the outcome of rheumatoid arthritis was not recovered, the outcome of euflexxa was not effective was not recovered, the outcome of headache was not recovered, the outcome of aching again [knee] was not recovered, the outcome of in the past she has had all three injections at once was recovered, the outcome of swelling in her knee went down was recovered. No concomitant medication was reported. The event rheumatoid arthritis was reported as serious. The events euflexxa was not effective, headache, in the past she has had all three injections at once, swelling in her knee went down, aching again [knee] were reported as non-serious. At the time of reporting the case outcome was not recovered. Overall listedness (core label) is unlisted. Reporter causality: related company causality: related to "arthralgia, headache, and joint swelling" and not related "rheumatoid arthritis " other case numbers: (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 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. Ferring's sender comment: association of euflexxa to rheumatoid arthritis is unrelated due to lack of biological plausibility. Contribution of euflexxa to arthralgia, headache, and joint swelling events cannot be ruled out based on the known safety profile of the drug. Therapeutic product effect decreased and product use issue events are related and listed as per ferring's conventions.
 
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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,
Manufacturer (Section G)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
be'er tuvia industrial zone
pob 571
kiryat malachi,
Manufacturer Contact
100 interpace parkway
parsippany, nj 
MDR Report Key10029204
MDR Text Key196919751
Report Number3000164186-2020-00009
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 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
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 Received04/24/2020
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: 05/06/2020 Patient Sequence Number: 1
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