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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Spontaneous call from pt wanted to know how frequently she can get the synvisc one.Informed pt that it is usually every 6 months.Patient asked because she feels the medication is not working for her.She has gotten the weekly injections for 3 weeks before which she thinks worked better but she doesn't recall the name of it.Informed pt to notify the mdo about medication not working.No further information obtained.Reported to (b)(6)/caremark by pt/caregiver.

• Brand Name: SYNVISC ONE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 13666917
• MDR Text Key: 286657275
• Report Number: MW5107888
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female