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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORP. SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORP. SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 04/28/2018
Event Type  Injury  
Event Description
Received outpatient injection of 4ml of synvisc (hyaluronic acid) in left knee on (b)(6) 2018 (13:00 ct) at orthopedic surgery and sports medicine outpatient clinic (opc building, floor 25) of houston methodist hospital. Suffered severe effusion and joint pain 48-96 hours post injection. Still difficult to walk on left leg 5 days post-injection. Case reports (publications) call this a type iv immune response similar to a positive tb test, since this is my 3rd injection over a 5 year period (already exposed to antigen). Suspect: yes. Primary: yes. Product type: drug/biologic. Synviscone. Com. Strength: 4 ml millilitre(s). Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Did the problem return if the person started taking or using the product again: yes. Do you still have the product in case we need to evaluate it: no. Quantity: other: 1 injection. How was it taken or used: injected in synovial sac. Date the person first started taking or using the product: (b)(6) 2015. Date the person stopped taking or using the product: (b)(6) 2018.
 
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Brand NameSYNVISC ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORP.
MDR Report Key7486209
MDR Text Key107489511
Report NumberMW5077003
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 05/03/2018 Patient Sequence Number: 1
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