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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML ACID, HYALURONIC, INTRAARTICULAR

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FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number P10006A
Device Problem Expiration Date Error (2528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2019
Event Type  malfunction  
Event Description
Dr's office received euflexxa but one of the syringes has a different lot number and expiration date than the other two syringes. That one syringe has an expired lot number of p10006a with expiration date of 10/21/2019.
 
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Brand NameEUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key9384397
MDR Text Key168465942
Report NumberMW5091345
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 Other Health Care Professional
Type of Report Initial
Report Date 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/21/2019
Device Lot NumberP10006A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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