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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI - AVENTIS U.S. LLC SYNVISC ONE
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SANOFI - AVENTIS U.S. LLC SYNVISC ONE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Pain (1994); Disability (2371); Reaction (2414)
Event Date 06/08/2014
Event Type  Injury  
Event Description
Had synvisc one injections for first time in both knees on (b)(6) 2014.Began having inflammatory reaction that started (b)(6) 2014 and became debilitating (b)(6) 2014.Rec'd emergency care and 90cc fluid drained from both knees (total) on (b)(6) 2014.Had to use a walker to go anywhere on (b)(6) 2014 (provided by emergency room).Rx for prednisone (10 days) of fluid being removed helped, but recovery is still ongoing as of today (b)(6) 2014.I went from a healthy, very active cyclist-riding 65 miles/day on a bike to being crippled.Had temperature of 100.9 on (b)(6) 2014.Emergency room was watching for "septic knee" - horrible experience.This was a potentially life threatening event.I am so thankful i can even walk at this point.This was my first emergency room visit ever.I have a high tolerance to pain and this crippled me.Horrible.Quantity: 1 injection both knees, frequency: 1st treatment, how was it taken or used: injection.Date the person first started taking: (b)(6) 2014.Why was the person using the product: looking for relief from minor knee pain associated with mild osteoarthritis.Severe inflammatory event in both knees, fever, swelling, immobility/disability.
 
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Brand Name
SYNVISC ONE
Type of Device
SYNVISC ONE
Manufacturer (Section D)
SANOFI - AVENTIS U.S. LLC
MDR Report Key3913284
MDR Text Key4518703
Report NumberMW5037033
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Patient Sequence Number1
Treatment
LEVOTHYROXINE 0.75 MG/1XDAY
Patient Outcome(s) Other; Disability;
Patient Age54 YR
Patient Weight75
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