MAUDE Adverse Event Report: GENZYME SYNVISC

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

Pt has been on synvisc for 11 years and had no adverse drug event but for the most recent series, pt experienced severe leg swelling and knees could not bend at joint.She had to apply ice packs for a few weeks in order for the swelling to resolve.Md thinks it's an allergic reaction.Md is considering switching her to a different hyaluronic and derivative.Dose or amount: 16 mg.Frequency: once a week for 3 weeks into left knee.Route: ia.Dates of use: (b)(6) 2008 to (b)(6) 2017.Diagnosis or reason for use: m17.12 osteoarthritis of left knee.

• Brand Name: SYNVISC
• Type of Device: SYNVISC
• Manufacturer (Section D): GENZYME
• MDR Report Key: 6621412
• MDR Text Key: 77192919
• Report Number: MW5070227
• Device Sequence Number: 1
• Product Code: MOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other