MAUDE Adverse Event Report: SYNVISC 8MG/ML 2ML PFS; NONE

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Ambulation Difficulties (2544)

Event Date 11/20/2014

Event Type  Injury  

Event Description

The member has a "semi frozen" feeling in the right knee.She is complaining that she has some hard type fluid on the top of her knee.It is "hard to the touch" and swelled up she only has about 25 percent mobility in the right knee and is still limping.The left knee has responded fine ot the medication.She denies any pain or redness, just this hard-swelled up area on right knee.Dose or amount: once syringe.Frequency: once weekly.Route: intra-articularly.

• Brand Name: SYNVISC 8MG/ML 2ML PFS
• Type of Device: NONE
• MDR Report Key: 4375379
• MDR Text Key: 19090061
• Report Number: MW5039844
• 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: 12/23/2014

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: Other
• Other Device ID Number: 58468-0090-01
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2014
• Patient Sequence Number: 1
• Patient Age: 56 YR