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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI / GENZYME HYALURONIC ACID, SYNVISC HYLAN

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SANOFI / GENZYME HYALURONIC ACID, SYNVISC HYLAN Back to Search Results
Lot Number 7RSL021
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sepsis (2067)
Event Date 12/06/2017
Event Type  Injury  
Event Description
Pt developed septic knee after injection on b)(6) 2017, hospitalized.Dose or amount: 16 mg milligram(s).Frequency: as needed.Route: intra-articular.Therapy start date: b)(6) 2017.Diagnosis or reason for use: knee pain.
 
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Brand Name
HYALURONIC ACID, SYNVISC HYLAN
Type of Device
HYALURONIC ACID, SYNVISC HYLAN
Manufacturer (Section D)
SANOFI / GENZYME
MDR Report Key7156974
MDR Text Key96235453
Report NumberMW5074327
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number7RSL021
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/29/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age27 YR
Patient Weight54
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