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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML ACID, HYALURONIC, INTRAARTICULAR

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BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2019
Event Type  Injury  
Event Description
Pt is using euflexxa off-label for shoulder pain.
 
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Brand NameEUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
MDR Report Key9468071
MDR Text Key171555825
Report NumberMW5091663
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier55566410001
UDI-Public55566410001
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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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