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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Weight Changes (2607)

Event Date 01/04/2018

Event Type  Injury  

Event Description

Patient is experiencing severe pain in both knees after knee injection as well as a ambulation difficulties, loss of appetite and weight loss.She states it's been 3 weeks with no pain relief.Patient went to the emergency room (er) and fluid was drained from her knees, but did not help with pain relief.Patient also received cortisone injections, also with no relief.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME; unk
• MDR Report Key: 7227958
• MDR Text Key: 98645623
• Report Number: MW5074962
• Device Sequence Number: 0
• 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: Patient
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 80