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

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

Patient Problems Nausea (1970); Pain (1994); Ambulation Difficulties (2544); Alteration in Body Temperature (4568); Swelling/ Edema (4577)

Event Date 09/08/2022

Event Type  Injury  

Event Description

Reporter complained of having pain, face swelling, feeling hot, nausea and difficulty walking after having a knee pain injection.She states the reaction is more worse compared to her initial previous knee injection back in 2016.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 15428494
• MDR Text Key: 300210257
• Report Number: MW5112069
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female