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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUFLEXXA

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EUFLEXXA Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missed Dose (2561)
Event Type  Injury  
Event Description
Patient reported she is in hospital due to illness and will miss therapy. No onset date was provided. Arxwp has not yet filled euflexxa for the patient. Frequency: other, weekly for 3 weeks.
 
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Brand NameEUFLEXXA
Type of DeviceEUFLEXXA
MDR Report Key7600656
MDR Text Key111292880
Report NumberMW5077856
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 Patient
Type of Report Initial
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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