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U.S. Department of Health and Human Services

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

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SANOFI / GENZYME CORPORATION SYNVISC ONE 6CC ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameSYNVISC ONE 6CC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SANOFI / GENZYME CORPORATION
MDR Report Key12985017
MDR Text Key282217794
Report NumberMW5105965
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/10/2021 Patient Sequence Number: 1
Treatment
METANX (COMPOUNDED MEDICATION) TWICE A DAY ; NEUROTIN 300 MG - 4 TIMES A DAY; PLAQUIENIL TWICE A DAY
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