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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 01/01/2019
Event Type  Injury  
Event Description
Pt stated synvisc one failed to give her relief for the full 6 months. She stated it barely lasted 3 months and wanted to know if she could get the medication every 3 months going forward. She is trying a new medication for this administration.
 
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Brand NameSYNVISC ONE INJ 8MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key8749407
MDR Text Key149835475
Report NumberMW5087725
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 06/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2019
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? 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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