MAUDE Adverse Event Report: SYNVISC-ONE

Device Problem Particulates (1451)

Patient Problem Nausea (1970)

Event Date 01/15/2011

Event Type  Injury  

Event Description

Had injection of synvisc-one in knee in (b)(6) 2011.I suffered several adverse effects including, flushing of face, nausea/vomiting, heat intolerance, prickly feeling.Also, for several months after injection, i shed sparkling crystals.If i wore black, the crystals were evident on my clothes.

• Brand Name: SYNVISC-ONE
• Type of Device: SYNVISC-ONE
• MDR Report Key: 4044915
• MDR Text Key: 4861914
• Report Number: MW5037907
• 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: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Weight: 82