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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR

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BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number R13626A
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Inflammation (1932); Ambulation Difficulties (2544)
Event Date 07/31/2020
Event Type  Injury  
Event Description
The patient had a severe inflammatory reaction to euflexxa a hyaluronic acid injection. This is a known possible side effect. However, the inflammatory reaction usually subsides within a few weeks. However, the inflammatory reaction has been permanent. I reached out to the company that manufactures euflexxa and they said they would test the lot, but i have not been able to get a response despite multiple inquiries. She and multiple joint aspirations and cortisone injections, which did not improve her symptoms. The patient tried arthroscopic knee surgery, which did not improve her symptoms. All infectious markers and cultures have been negative. She is seeing a rheumatologist which is treating for an inflammatory condition. However, she will has made little progress. She has not been able to walk for almost a year now and she will likely need a left knee replacement and right toe fusion, but she will likely have lifelong disability from this issue. Injection material: lot# r13626a, exp-03/28/2021.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
MDR Report Key11912412
MDR Text Key253713783
Report NumberMW5101620
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2021
Device Lot NumberR13626A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 05/28/2021 Patient Sequence Number: 1
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