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U.S. Department of Health and Human Services

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

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FERRING PHARMACEUTICALS INC / BIO-TECHNOLOGY GENERAL (ISRAEL) 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 07/08/2019
Event Type  No Answer Provided  
Event Description
Physician has prescribed medication for the off label use of intra-articular injection into both of pt's shoulders. Physician is aware of labeled indications of this medication and wishes to proceed.
 
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Brand NameEUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC / BIO-TECHNOLOGY GENERAL (ISRAEL)
MDR Report Key8790723
MDR Text Key151288965
Report NumberMW5088106
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 07/08/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received07/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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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