MAUDE Adverse Event Report: SYNVISC ONE INJ 8MG/ML

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

Event Date 12/09/2016

Event Type  Injury  

Event Description

Pt is experiencing significant pain and swelling in the knee injection was administered to.It is 2 days following injection.Pt reports to two previous injections in 2013 and 2014 without any similar reactions.Diagnosis or reason for use: (b)(4).Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: SYNVISC ONE INJ 8MG/ML
• MDR Report Key: 6173799
• MDR Text Key: 62404082
• Report Number: MW5066699
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 12/09/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR