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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORP. SYNVISC INJ 8MG/ML (3X2ML) ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORP. SYNVISC INJ 8MG/ML (3X2ML) ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missed Dose (2561)
Event Date 04/02/2020
Event Type  Injury  
Event Description
Patient received the first two doses of her synvisc for her right knee for osteoarthritis but due to covid19, she was unable to receive the remaining injection. Patient was concerned about her therapy and the stability of the medication. Advised the patient the medication will still be stable at room temperature up until the expiration date. Regarding patient's therapy, she might not experience the full benefits since she didn't get all 3 doses.
 
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Brand NameSYNVISC INJ 8MG/ML (3X2ML)
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORP.
MDR Report Key9932900
MDR Text Key186779199
Report NumberMW5094044
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 Pharmacist
Type of Report Initial
Report Date 04/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2020
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
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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