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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION SYNVISC ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 04/22/2020
Event Type  Injury  
Event Description
Patient reported being hospitalized with covid-19 from (b)(6) 2020 to (b)(6) 2020 and also that his synvisc medication is ineffective so his doctor will be prescribing him a new therapy. Diagnosis for use: unilateral primary osteoarthritis right knee.
 
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Brand NameSYNVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key11010326
MDR Text Key221518033
Report NumberMW5098329
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 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 12/11/2020 Patient Sequence Number: 1
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