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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC-ONE ACID, HYALURONIC, INTRAARTICULAR
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GENZYME CORPORATION SYNVISC-ONE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Model Number HYLAN G-F-20
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Arthralgia (2355)
Event Date 12/12/2017
Event Type  malfunction  
Event Description
Patient received an ultrasound guided injection of synvisc-one. Patient presented with left knee pain and reports stabbing pain began at approximately 16:00 that same day (approximately 8 hours post injection). Growth of a gram negative bacillus was detected from the synovial fluid culture collected. Manufacturer has issued a recall.
 
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Brand NameSYNVISC-ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7326973
MDR Text Key101993136
Report Number7326973
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 User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHYLAN G-F-20
Other Device ID NumberP940015
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/16/2018
Event Location No Information
Date Report to Manufacturer02/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2018 Patient Sequence Number: 1
Treatment
OTHER, PATIENT RECEIVED AN ULTRASOUND GUIDED INJ
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