MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC (3X2MM PREFILLED SYR); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Pain (1994); Swelling (2091); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/06/2019

Event Type  Injury  

Event Description

Injection site reaction with last dose (b)(6) 2019.No other doses had this reaction.Swelling, water retention, and limited mobility of knee.Injection site pain.

• Brand Name: SYNVISC (3X2MM PREFILLED SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 8487167
• MDR Text Key: 141097926
• Report Number: MW5085601
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2019
• Patient Sequence Number: 0