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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME SYNVISC ACID, HYALURONIC, INTRAARTICULAR

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GENZYME SYNVISC ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Pain (1994)
Event Date 10/05/2020
Event Type  Injury  
Event Description
Dr added gabapentin 100 mg 2/day and 300 mg at night for nerve pain.
 
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Brand NameSYNVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME
MDR Report Key10770166
MDR Text Key214369659
Report NumberMW5097575
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 Unknown
Type of Report Initial
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
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
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/30/2020 Patient Sequence Number: 1
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