MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/20/2019

Event Type  Injury  

Event Description

Pt called in; wanted to know when she will start feeling with her knee. Mdo told her that 10-14 days after the injection she should experience relief. Pt is comparing relief she gets with cortisone with synvisc one. Explained to her one is a "band aid" for her problem, the other is building up the joint again. She asked if she could still get a cortisone injection if she already got a synvisc shot. Informed her she could.

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 8650924
• MDR Text Key: 146498221
• Report Number: MW5086970
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

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