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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORP. SYNVISC INJ 8MG/ML (3 X 2 ML) ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORP. SYNVISC INJ 8MG/ML (3 X 2 ML) 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 08/29/2018
Event Type  Injury  
Event Description
Received enrollment form drug listed on form is synvisc (box checked for synvisc). (b)(6)call stated medication needed was synvisc-one. Took doe for synvisc-one medication has not been given to pt, (b)(6) requesting synvisc-one be shipped. Spoke with (b)(6) at (b)(6). Dates of use: (b)(6) 2018 - present. Diagnosis or reason for use: osteoarthritis. Is the product compounded? no. Is the product over-the-counter? no.
 
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Brand NameSYNVISC INJ 8MG/ML (3 X 2 ML)
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORP.
1 research drive
west borough MA 01581
MDR Report Key7850861
MDR Text Key119572340
Report NumberMW5079617
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 Pharmacist
Type of Report Initial
Report Date 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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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