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

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Arthralgia (2355); Joint Swelling (2356)

Event Date 11/28/2017

Event Type  Injury  

Event Description

Received synvisc-one to right knee.Less than 24 hours post injection - knee pain, significant swelling, and redness.Dose or amount: 48 mg milligram(s).Route: intra-articular.Therapy start date: (b)(6) 2017.Therapy end date: (b)(6) 2017.Diagnosis or reason for use: primary osteoarthritis.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7154330
• MDR Text Key: 96179464
• Report Number: MW5074275
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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 Age: 64 YR
• Patient Weight: 116