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

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

Patient Problems Fever (1858); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 01/28/2021

Event Type  Injury  

Event Description

I had an injection of synvisc one at approximately 930 am.I've had two of these injections previously.One in (b)(6) 2020 and another in (b)(6) 2020 with no issues.Around 8pm the swelling in the knee joint became painful.The pain and swelling increased and around 10 pm i became feverish.At midnight, the fever was 100 f.I took tylenol at midnight and advil at 2 am.As of 8 am on (b)(6), the fever seems to be gone but the joint is still quite swollen and painful and it is difficult to bear weight on that leg.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11265579
• MDR Text Key: 230065228
• Report Number: MW5099134
• 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: Patient
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 85