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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI-AVENTIS U.S. LLC SYNVISC-ONE VISCOSUPPLEMENT GEL ACID, HYALURONIC, INTRAARTICULAR

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SANOFI-AVENTIS U.S. LLC SYNVISC-ONE VISCOSUPPLEMENT GEL ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problems Nonstandard Device (1420); Product Quality Problem (1506)
Patient Problems Death (1802); Emotional Changes (1831); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Respiratory Distress (2045); Tachycardia (2095); Blurred Vision (2137); Visual Impairment (2138); Burning Sensation (2146); Dizziness (2194); Depression (2361); Neck Stiffness (2434); Chest Tightness/Pressure (2463); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)
Event Date 01/01/2017
Event Type  Death  
Event Description
My husband had a bad reaction to a synvisc-one injection in his knee, he received at andrews-sport medicine in (b)(6) by dr (b)(6), (b)(6) 2017. It was told to us that it was a bad batch and sent back to the mfr sanofi-aventis group. He continued to follow dr's orders and saw the dr about his knee getting worse and worse. Continuously got worse, the dr just said take tylenol and use ice on knee. He took a list of how he was feeling, still with serious pain and other things that was going on with his body. He could hardly walk but went to the dr telling him he can't stand it. We returned to the dr many times and he wasn't being checked out on any possible side effects he was complaining about. My husband keep telling me and our son he couldn't handle it much more, within the next 44 days it was more than my husband of 43 years could bare, i had never seen him like this. On (b)(6) 2017, he took his own life. On (b)(6) dr (b)(6) called to say the shot was found contaminated and that the lot of injections were being recalled. At that time, it was too late to help my husband. But it all made sense as to what had taken over his body and mind and all that he was experiencing and trying to tell us. Later i found out that the drs may have known earlier, as the recall had been announced in a press release on december 11th, yet we weren't told in time to have saved my husband's life. A month out from his shot his horrible adverse reaction he still had debilitating pain, fatigue, periods of breathing difficulties, racing heart and cough, chest pressure, stickiness inside his mouth, loss of coordination and balance and some short term memory loss, dizzy spells, intense burning that started with his knee injection and burned down through the lower leg, numb legs and feet, extreme tightness behind the knee, vision changes including blurring and visual movement, drastic body temperature changes, severe mood swings and depression and a terrible feeling of pressure in his head, extreme headaches, stiffness in his neck. I have lots of notes but will stop now until you want more info. How was it taken or use? subcutaneous; date the person first started taking or using the product: (b)(6) 2017; date the person stopped taking or using the product: (b)(6) 2017. Reason for use: replace lost of fluid in his knee from a bakers cyst burst.
 
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Brand NameSYNVISC-ONE VISCOSUPPLEMENT GEL
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SANOFI-AVENTIS U.S. LLC
MDR Report Key8128888
MDR Text Key129436250
Report NumberMW5081796
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
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
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: 12/21/2018 Patient Sequence Number: 1
Treatment
COREG 6.25 MG; FLO-MAX 0.4 MG; LOSARTAN 100 MG; TRAZODONE 100 MG; TYLENOL
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