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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENEZYME CORPORATION SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR

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GENEZYME CORPORATION SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Local Reaction (2035); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Patient reports that after receiving injections, she had reactions and needed knee drained. She says reactions were so severe that she almost ended up in hospital, the event happened on (b)(6) 2020.
 
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Brand NameSYNVISC ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENEZYME CORPORATION
MDR Report Key12370183
MDR Text Key268459990
Report NumberMW5103500
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 Unknown
Type of Report Initial
Report Date 08/23/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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
Is This a Reprocessed and Reused Single-Use Device?

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