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

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.

• Brand Name: HYALURONIC ACID, SYNVISC HYLAN
• Type of Device: HYALURONIC ACID, SYNVISC HYLAN
• Manufacturer (Section D): SANOFI / GENZYME
• MDR Report Key: 7156974
• MDR Text Key: 96235453
• Report Number: MW5074327
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 7RSL021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR
• Patient Weight: 54