MAUDE Adverse Event Report: SANOFI / GENZYME CORPORATION SYNVISC ONE 6CC; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Headache (1880); Muscle Weakness (1967); Neuropathy (1983); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Date 07/27/2021

Event Type  Injury  

Event Description

Synvisc one injection to both knees by (b)(6).Resulted in muscle weakness, lack of coordination, extreme swelling of knees and lower legs, severe muscle spasms, muscle weakness, and severe headache causing two trips to the emergency room.Followed by multiple doctor visits to primary care, rheumatologist, physical medicine, and neurologist.The neurologist, this week, finally diagnosed moderate to severe neuropathy.Been placed on three medications as a result of the event, plaquenil twice a day, metanx (compounded medication) twice a day and neurontin 300 mg - 4 times a day.Injections have made knees worse and caused toxic problems.There was a question in my mind at the time that cortisone was not injected at the same time the synvisc one was.

• Brand Name: SYNVISC ONE 6CC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SANOFI / GENZYME CORPORATION
• MDR Report Key: 12985017
• MDR Text Key: 282217794
• Report Number: MW5105965
• 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
• Type of Report: Initial
• Report Date: 12/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: METANX (COMPOUNDED MEDICATION) TWICE A DAY ; NEUROTIN 300 MG - 4 TIMES A DAY; PLAQUIENIL TWICE A DAY
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White