MAUDE Adverse Event Report: GENZYME CORP SYNVISC ONE

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.

• Brand Name: SYNVISC ONE
• Type of Device: SYNVISC ONE
• Manufacturer (Section D): GENZYME CORP
• MDR Report Key: 5586814
• MDR Text Key: 43019233
• Report Number: MW5061761
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 04/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/22/2016
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 73