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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 Therapy Delivered to Incorrect Body Area (1508)
Patient Problem Pain (1994)
Event Date 05/30/2019
Event Type  No Answer Provided  
Event Description
The pt stated the injection for the medication was given into the wrong spot in his knee and was not effective. He is requiring another injection of the medication as he is in a lot of pain.
 
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Brand NameSYNVISC ONE INJ 8MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key8749401
MDR Text Key149945891
Report NumberMW5087724
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier58468009003
UDI-Public58468009003
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 06/21/2019
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? No
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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