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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION SYNVISC ONE PFS 8MG/ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problem Insufficient Information (4580)
Event Date 04/01/2021
Event Type  Injury  
Event Description
The doctor's office confirmed this patient is being treated with synvisc-one for his left knee and also bilateral shoulders. The dr is aware of off-label dosing of synvisc-one for the shoulders and wants to continue.
 
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Brand NameSYNVISC ONE PFS 8MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key11613201
MDR Text Key244035604
Report NumberMW5100545
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 Other Health Care Professional
Type of Report Initial
Report Date 04/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2021
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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