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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUFLEXXA INJ 10MG/ML ACID, HYALURONIC, INTRAARTICULAR

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EUFLEXXA INJ 10MG/ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missed Dose (2561)
Event Date 03/23/2018
Event Type  Injury  
Event Description
Missed dose consult. Euflexxa 20mg pfs last year; 1 dose missed got 2 of 3 injections but, no issues with therapy. Pt continuing next series of injections. No adr reported. "is the product compounded: no, is the product over-the-counter: no. ".
 
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Brand NameEUFLEXXA INJ 10MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
MDR Report Key7373266
MDR Text Key103696989
Report NumberMW5076161
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
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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