MAUDE Adverse Event Report: SANOFI GEYZYME SYNVISC ONE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 7RSL021

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Sleep Dysfunction (2517); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/08/2017

Event Type  Injury  

Event Description

Pt reported swelling knee right knee is tight remained painful and effected sleep and mobility.Therapy date: (b)(6) 2017.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SANOFI GEYZYME
• MDR Report Key: 7203018
• MDR Text Key: 97734562
• Report Number: MW5074671
• 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: 01/15/2018

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1