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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNVISC ONE

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SYNVISC ONE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Diarrhea (1811); Headache (1880); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Vomiting (2144); Joint Swelling (2356); Ambulation Difficulties (2544)
Event Date 11/08/2017
Event Type  Injury  
Event Description
I had the synvisc one injection in my knee on the morning of (b)(6) 2017, and within a few hours, my knee and leg were double their normal size. By evening i was in excruciating pain and couldn't bear weight on that leg. I called the doctors office the following day and was asked to come in asap. I was told that the injection that i had received was from a lot that had caused numerous people to have extreme side effects, and they were being told not to give any further injections from that lot. I've had to have fluid drained from my knee on two separate occasions, and two weeks out, my knee and leg are still painful and swollen. I've had nausea, vomiting, diarrhea, headache and have felt generally ill since receiving the injection. I was on crutches for several days following the injection, and i still can't bend my knee completely. I have been diagnosed with a uti as well. I had none of these symptoms prior to the injection. 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. Did the person stop after the person reduced the dose or stopped taking or using the product: no. Do you still have the product in case we need to evaluate it: no.
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Type of DeviceSYNVISC ONE
MDR Report Key7063981
MDR Text Key93285116
Report NumberMW5073599
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 11/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
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: 11/28/2017 Patient Sequence Number: 1