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

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

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 09/10/2005

Event Type  No Answer Provided  

Event Description

Pt got a synvisc injection the day before.Came in after developing right knee swelling and painful spasm.Pt was using crutches at home; 47 cc of yellow fluid was removed from right knee with some immediate relief.A repeat arthrocentesis 2 days later for pain relieve.Kenalog 20g was also administered to joint.Rheumatology felt it was an allergic reaction to synvisc; (hylan g-f).

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10829312
• MDR Text Key: 216185771
• Report Number: MW5097801
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR