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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. HYALURONATE SODIUM (HYALURONATE NA (EUFLEXXA) 10MG/ML INJ, SYRINGE, 2ML ACID, HYALURONIC, INTRAARTICULAR

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BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. HYALURONATE SODIUM (HYALURONATE NA (EUFLEXXA) 10MG/ML INJ, SYRINGE, 2ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthralgia (2355); Swelling/ Edema (4577)
Event Date 07/02/2021
Event Type  No Answer Provided  
Event Description
Joint pain and swelling. Suspect drug#1, dosing: injection into knee. Diagnose for use: pain.
 
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Brand NameHYALURONATE SODIUM (HYALURONATE NA (EUFLEXXA) 10MG/ML INJ, SYRINGE, 2ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
MDR Report Key12452637
MDR Text Key271237334
Report NumberMW5103818
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 Pharmacist
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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