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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 03/08/2018

Event Type  Injury  

Event Description

Patient reported experiencing swelling in her right knee which caused her immobility, and she needed physical therapy and acupuncture to treat.She stated that it worsened her osteoarthritis and increased her pain.Lot number and expiration dates unknown at this time, but the pharmacy is investigating.

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: SYNVISC ONE INJ 8MG/ML
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7330472
• MDR Text Key: 102197359
• Report Number: MW5075804
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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: 72 YR