MAUDE Adverse Event Report: GENZYME CORP. SYNVISC ONE 45MG/6ML; ACID HYALURONIC

Lot Number 7RSL021

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Pain (1994); Swelling (2091)

Event Date 11/14/2017

Event Type  Injury  

Event Description

Synvisc one injected intraarticular right knee within 24 hours patient experienced severe pain, swelling, stiffness.Dose or amount: 48 mg/6 ml.Frequency: six months.Route: intraarticular.Dates of use: (b)(6) 2017.Diagnosis or reason for use: m17.11 right knee djd.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: SYNVISC ONE 45MG/6ML
• Type of Device: ACID HYALURONIC
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 7288834
• MDR Text Key: 100838059
• Report Number: MW5075407
• 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: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• 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): Other
• Patient Age: 72 YR
• Patient Weight: 70