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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING EUFLEXXA

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FERRING EUFLEXXA Back to Search Results
Lot Number 6309501100
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)
Event Date 03/07/2016
Event Type  Injury  
Event Description
Was given a series of shots to improve my mobility and pain and had to pay a large co-pay and as a result of taking euflexxa i have more pain and can hardly move one of my legs. I work and it has really become a problem for me with the pain and mobility. I have had other treatments and they worked as they were supposed to and had so much more pain control. The euflexxa actually increased my pain.
 
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Brand NameEUFLEXXA
Type of DeviceEUFLEXXA
Manufacturer (Section D)
FERRING
MDR Report Key5532287
MDR Text Key41455528
Report NumberMW5061298
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number6309501100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/24/2016 Patient Sequence Number: 1
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