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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORP SYNVISC ONE

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GENZYME CORP SYNVISC ONE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Weakness (2145)
Event Date 04/13/2016
Event Type  Injury  
Event Description
I was so very tired and weak, could barely make it into the house. Got in chair and all of a sudden, i started to throw up, went back to lay down and had to get up again immediately. And threw up. Back and forth until a little after midnight, it finally quit. Headache, and now the nausea is back again, started about 8am this morning. I called doctor they will call me back. I'm allergic to a lot of things but not chicken. On a scale of one to 10, the pain is a 10. I'm shaking i'm so nauseated. Diagnosis or reason for use: torn muscle in knee and no cartilage. Event abated after use stopped or dose reduced: no.
 
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Brand NameSYNVISC ONE
Type of DeviceSYNVISC ONE
Manufacturer (Section D)
GENZYME CORP
MDR Report Key5586814
MDR Text Key43019233
Report NumberMW5061761
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 04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/22/2016
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: 04/14/2016 Patient Sequence Number: 1
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