MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Pain (1994); Synovitis (2094); Swelling/ Edema (4577)

Event Date 01/28/1999

Event Type  Injury  

Event Description

Patient received series of synvisc on left knee.Patient developed significant swelling and pain in knee after first injection of synvisc on (b)(6) 1999.Pt went on trip to mexico in between first and second injection, so did not come in for follow-up visit.Symptoms resolved, and patient received second and third injection of synvisc - (b)(6) 1999, respectively.No intervention was required.Assessment: acute synovitis.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10816427
• MDR Text Key: 216185947
• Report Number: MW5097755
• 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: 05/03/2000

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR