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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION SYNVISC KNEE INJECTION ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number 9RSPO14A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Chills (2191); Decreased Appetite (4569)
Event Date 08/25/2020
Event Type  Injury  
Event Description
Had synvisc injection in the left knee on (b)(6) 2020 at the (b)(6) center located at (b)(6) by dr. (b)(6). On (b)(6) 2020 i developed a fever of 101. 5, headache, nausea, chills, loss of appetite, and leg pains. These symptoms lasted on and off treated with tylenol prn thru (b)(6) 2020. I had the same reaction when injected in the left knee with synvisc on (b)(6) 2020 with illness starting on (b)(6) 2020 with symptoms of fever of 101, headache, nausea, chills, loss of appetite, and leg pains. Symptoms lasted on and off treated with tylenol prn. The lot # for the synvisc administered on (b)(6) 2020 was 9rspo14a, exp 2022-07. The lot number for the synvisc administered on (b)(6) 2020 was 9rspo12a, exp 2022-05.
 
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Brand NameSYNVISC KNEE INJECTION
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key10975703
MDR Text Key220690564
Report NumberMW5098261
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 Patient
Type of Report Initial
Report Date 12/06/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number9RSPO14A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
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