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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Loss of consciousness (2418); Contact Dermatitis (4546)
Event Type  No Answer Provided  
Event Description
Received an injection in the knee of synvisc-one hylan g-f 20 but within minutes after the injection, i passed out for a little over an hour at the doctors office, (b)(6). After revival, went home and about my business but that evening i developed a severe rash on both shoulders and neck which is being treated with benadryl. The rash is hundreds of small hard pimples. But confined to shoulders and neck. Dermatitis, acneiform, loss of consciousness.
 
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Brand NameSYNVISC ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key10844226
MDR Text Key216671730
Report NumberMW5097914
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 02/07/2012
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

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