MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE; ACID HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 11/09/2017

Event Type  Injury  

Event Description

Non septic reaction to synvisc one.Therapy date: (b)(6) 2017.Diagnosis or reason for use: knee osteoarthritis."event abated after use stopped or dose reduced: yes.".

• Brand Name: SYNVISC ONE
• Type of Device: ACID HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 7112071
• MDR Text Key: 94850347
• Report Number: MW5073930
• 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: Physician
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 47 YR
• Patient Weight: 81