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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUFLEXXA SODIUM HYALURONATE

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EUFLEXXA SODIUM HYALURONATE Back to Search Results
Device Problems Unstable (1667); Noise, Audible (3273)
Patient Problems Pain (1994); Rash (2033); Chills (2191); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/16/2016
Event Type  Injury  
Event Description
After third injection of eufflexa had severe pain in left knee/joint, rash, chills, instability, trouble sleeping with severe pain. Pain was 4-5 on a scale of ten before injections. After injection, knee pain was a ten. I went to the emergency department as ordered by surgeon. They aspirated knee but could not get fluid. I was given a brace and pain medication. The severe pain (9-10) subsided (6-7) for about two weeks then reoccurred and the left knee has severe pain (10), instability, difficulty bearing weight on left leg, extreme pain at night while sleeping, occasional crepitus and cracking sounds from left knee, difficulty walking and difficulty with activities of daily living. Date the person first started taking or using the product: (b)(6) 2016. Date the person stopped taking or using the product: (b)(6) 2016. Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Why was the person using the product: osteoarthritis.
 
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Brand NameEUFLEXXA SODIUM HYALURONATE
Type of DeviceEUFLEXXA SODIUM HYALURONATE
MDR Report Key6311728
MDR Text Key66930128
Report NumberMW5067754
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2017
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? 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: 02/06/2017 Patient Sequence Number: 1
Treatment
ALBUTEROL; GUAIFENESIN OCCASIONALLY; IBUPROFEN ; LORATADINE OCCASIONALLY; MELATONIN OCCASIONALLY; OTC MEDS:MULTIPLE VITAMINS; QVAR; RANITADINE; RX MEDS: LEVOTHYROXINE; SUBLINGUAL B COMPLEX; SUDAFED OCCASIONALLY; TYLENOL; VITAMIN D
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