MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8MG/L (3X2 ML); ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Injury (2348); Joint Disorder (2373)

Event Date 07/19/2019

Event Type  Injury  

Event Description

Spoke with (b)(6) from dr's office and patient had an adverse reaction.The notes from dr indicated pt had a flare reaction knee effusion after first injection on both knees with synvisc per (b)(6), injection coordinator.

• Brand Name: SYNVISC INJ 8MG/L (3X2 ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 8826646
• MDR Text Key: 152456673
• Report Number: MW5088379
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• 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: 07/19/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR