• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FERRING PHARMACEUTICALS INC. / 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
Confirmed with dr's office that the prescriber is aware that euflexxa administered weekly for 5 weeks is off label and wants to continue to dispense as written.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC. / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
MDR Report Key9468081
MDR Text Key171556180
Report NumberMW5091664
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

-
-