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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 10 MG/ML 2ML ACID, HYALURONIC, INTRAARTICULAR

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FERRING PHARMACEUTICALS INC. EUFLEXXA 10 MG/ML 2ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number NOT REPORTED
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Event Description
Patient's daughter reported euflexxa did not work for patient two years ago the medication is ineffective. (b)(6).
 
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Brand NameEUFLEXXA 10 MG/ML 2ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key11154265
MDR Text Key226657098
Report NumberMW5098760
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 01/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberNOT REPORTED
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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